apollo endosurgery OverStitch ESS-G02-160 User manual

SINGLE PATIENT USE
DISPOSABLE
Caution:
Please read all instructions prior to use
GRF-00002-00R20
OverStitch™ Endoscopic Suturing System ESS-G02-160
OverStitch™ 2-0 Polydioxanone Suture PDO-G02-020
OverStitch™ 2-0 Polypropylene Suture PLY-G02-020
OverStitch™ 2-0 Polypropylene Suture PLY-G02-020-A
OverStitch™ 2-0 Polypropylene Suture PLY-G02-020-APL
OverStitch™ Suture Cinch CNH-G01-000
Tissue Helix THX-165-028
Product Code:
Dening the Future
of Endoscopic Surgery™
OverStitch™
English page 2
[Endoscopic Suturing System] (ESS)
INSTRUCTIONS FOR USE
Español página 8
[Sistema de sutura endoscópica]
INSTRUCCIONES DE USO
Deutsch Seite 14
[Endoskopisches Nahtsystem]
GEBRAUCHSANWEISUNG
Français page 20
[Système de suture endoscopique]
MODE D’EMPLOI
Italiano pagina 26
[Sistema di sutura endscopica]
ISTRUZIONI PER L’USO
Português página 32
[Sistema de sutura endoscópica]
INSTRUÇÕES DE UTILIZAÇÃO
Nederlands pagina 38
[Endoscopisch hechtsysteem]
GEBRUIKSAANWIJZING
Dansk side 44
[Endoskopisk sutureringssystem]
BRUGSANVISNING
Norsk side 50
[Endoskopisk sutureringssystem]
BRUKSANVISNING
Suomi sivu 56
[Endoskooppinen ommeljärjestelmä]
KÄYTTÖOHJEET
Svenska sidan 62
[Endoskopiskt sutureringssystem]
BRUKSANVISNING
Polski strona 68
[System do wziernikowego zakładania szwów]
INSTRUKCJA UŻYCIA
Čeština strana 74
[Endoskopický šicí systém]
NÁVOD K POUŽITÍ
Magyar oldal 80
[Endoszkópos varrógéprendszer]
HASZNÁLATI ÚTMUTATÓ
български страница 86
[Ендоскопска система за хирургични шевове]
ИНСТРУКЦИИ ЗА УПОТРЕБА
Eesti lk 92
[Endoskoopiline õmblussüsteem]
KASUTUSJUHEND
Srpski strana 98
[Sistem za endoskopsko ušivanje]
UPUTSTVO ZA UPOTREBU
Slovenčina strana 104
[Endoskopický šijací systém]
NÁVOD NA POUŽITIE
Slovenščina stran 110
[Endoskopski sistem za šivanje]
NAVODILA ZA UPORABO
Română pagina 116
[Sistem de sutură endoscopică] (SSE)
INSTRUCȚIUNI DE UTILIZARE
Українська сторінка 122
[Система накладання
ендоскопічного шва]
ІНСТРУКЦІЯ З ВИКОРИСТАННЯ
Ελληνικά σελίδα 128
[Σύστημα ενδοσκοπικής συρραφής]
ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ
Türkçe sayfa 134
[Endoskopik Sütür Sistemi]
KULLANMA TALİMATI
140  
[   ]
 
Bahasa Indonesia halaman 146
[Endoscopic Suture System]
(ESS/Sistem Jahitan Endoskopi)
PETUNJUK PENGGUNAAN

2
Table of Symbols
Single use only. Disposable. Do not resterilize.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Patent Pending.
DISCLAIMER OFWARRANTY AND LIMITATION OF REMEDY
THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, ON THE APOLLO ENDOSURGERY, INC. PRODUCT(S) DESCRIBED IN THIS PUBLICATION. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, APOLLO
ENDOSURGERY, INC. DISCLAIMS ALL LIABILITY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, REGARDLESS OF WHETHER SUCH LIABILITY IS
BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, PRODUCTS LIABILITY OR OTHERWISE. THE SOLE AND ENTIRE MAXIMUM LIABILITY OF APOLLO ENDOSURGERY,
INC., FOR ANY REASON, AND BUYER’S SOLE AND EXCLUSIVE REMEDY FOR ANY CAUSE WHATSOEVER, SHALL BE LIMITED TO THE AMOUNT PAID BY THE CUSTOMER
FOR THE PARTICULAR ITEMS PURCHASED. NO PERSON HAS THE AUTHORITY TO BIND APOLLO ENDOSURGERY, INC. TO ANY REPRESENTATION OR WARRANTY EXCEPT
AS SPECIFICALLY SET FORTH HEREIN. DESCRIPTIONS OR SPECIFICATIONS IN APOLLO ENDOSURGERY, INC PRINTED MATTER, INCLUDING THIS PUBLICATION, ARE MEANT
SOLELY TO GENERALLY DESCRIBE THE PRODUCT AT THE TIME OF MANUFACTURE AND DO NOT CONSTITUTE ANY EXPRESS WARRANTIES OR RECOMMENDATIONS FOR USE
OF THE PRODUCT IN SPECIFIC CIRCUMSTANCES. APOLLO ENDOSURGERY, INC. EXPRESSLY DISCLAIMS ANY AND ALL LIABILITY, INCLUDING ALL LIABILITY FOR ANY DIRECT,
INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, RESULTING FROM REUSE OF THE PRODUCT.
Description Symbol Description Symbol Description Symbol
Consult Instructions for Use Manufacturer Use By
Do Not Re-use
Caution: Federal law (USA) restricts
this device to sale by or on the order
of a physician
Lot Number
Sterilized Using Ethylene Oxide Date of manufacture Do not use if package is damaged
Reference Number Do Not Resterilize Authorized Representative in the
European Community
Medical Device Contains hazardous substance
1. Intended Use
The Apollo Endosurgery OverStitch™ Endoscopic Suture System (ESS) is intended for
endoscopic placement of suture(s) and approximation of soft tissue.
1.1 Contraindications
Contraindications include those specic to use of an endoscopic suturing system, and
any endoscopic procedure, which may include, but not limited to, the following:
• This system is not for use where endoscopic techniques are contraindicated.
• This system is not for use with malignant tissue.
1.2 Warnings
• Do not use a device where the integrity of the sterile packaging has been
compromised or if the device appears damaged.
• Only physicians possessing sufcient skill and experience in similar or the same
techniques should perform endoscopic procedures.
• Contact of electrosurgical components with other components may result in injury
to the patient and/or operator as well as damage to the device and/or endoscope.
• Verify compatibility of endoscopic instruments and accessories and ensure
performance is not compromised.
NOTE: Refurbished scopes may no longer confirm to original specifications.
• Ensure that there is sufcient space for the Needle to open.
• Ensure that the Handle Grip of the Endoscopic Suturing System is closed and
locked during intubation and extubation.
• Users should be familiar with surgical procedures and techniques involving
absorbable sutures before employing Synthetic Absorbable Sutures for wound
closure, as the risk of wound dehiscence may vary with the site of application and
the suture material used.
• Reuse or reprocessing of the OverStitch system could result in device malfunction
or patient consequences to include:
–Infection or the transmission of disease
–Failure of the handle mechanism causing the device to become locked on
tissue that may require surgical intervention
–Reduced retention on the Endoscope, causing the Endcap to detach during
use that may require surgical intervention to retrieve
–Reduced retention of the Anchor to the Needle Body, resulting in an
inadvertent Anchor drop causing procedural delay or requiring subsequent
intervention
–Bending of the Needle Body, preventing the physician from driving the
Needle correctly or performing the intended procedure
–Failure of the Helix to extend fully, limiting the ability to acquire tissue and
perform intended procedure
• If subject device is used to oversew foreign objects, such as staples, stents,
clips or mesh, it is possible for the needle to become trapped in the foreign body,
requiring surgical intervention.
• In situations where the operative site poses a risk of harm to adjacent anatomic
structures, use of endoscopic accessories such as the OverStitch Tissue Helix
is recommended to retract the tissue intended to be sutured away from these
unseen structures.
1.3 Precautions
• The System may only be used if purchased from Apollo Endosurgery, Inc. or one of
its authorized agents.
• With the Endoscopic Suturing System installed, the endoscope’s primary channel
effectively becomes a 3.2 mm channel.
• An overtube with an internal diameter of at least 16.7 mm may be used with the
system to protect the esophagus.
1.4 System Compatibility
The OverStitch ESS is compatible with the sutures identified on Page 1.
The OverStitch is compatible with the following endoscopes:
• Olympus 2T160, 2TH180, or 2T240
• Fuji EI-740D/S
Availability of compatible devices may vary depending on geography.
1.5 Adverse Events
Possible complications that may result from using the Endoscopic Suturing System
include, but may not be limited to:
• Pharyngitis / Sore throat
• Nausea and / or Vomiting
• Abdominal pain and / or Bloating
• Hemorrhage
• Hematoma
• Conversion to laparoscopic or open procedure
• Stricture
• Infection / Sepsis
• Pharyngeal, colonic and/or esophageal perforation
• Esophageal, colonic and/or pharyngeal laceration
• Intra-abdominal (hollow or solid) visceral injury
• Aspiration
• Wound dehiscence
• Acute inflammatory tissue reaction
• Death
NOTE: Any serious incident that has occurred in relation to the device should be reported
to Apollo Endosurgery (see contact information at the end of this document) and any
appropriate government entity.
English

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English
2. Packaged System
3. Nomenclature
Needle Driver & Anchor
Exchange
Package 1
Package 2
Package 3 Package 4
Polydioxanone (absorbable) -
VIOLET
Polypropylene (nonabsorbable) - BLUE
Endoscope
{ }
Needle Driver
Endcap
Anchor Exchange
Anchor Release Button
Needle Driver Handle
Endoscope Handle
Suture Assembly
Anchor Body
Suture
Helix Tip
Helix
Helix Handle
Cinch
Cinch Handle
Collar Plug
Suture Loading Loop
Helix
(AVAILABLE SEPARATELY)
Cinch
Suture Assembly

4
English
4. Assembly
4.1. Place the compatible endoscope on a suitable
surface for assembly.
NOTE: Ensure standard channel valves are tted to
working channels.
4.2. Remove Needle Driver from packaging.
4.3. Close Needle Body.
‘click’
NOTE: Ensure Endcap is not dropped or otherwise
damaged.
4.4. Push alignment tube into the primary working
channel until Endcap is ush with Endoscope face.
NOTE: Resistance should be felt when attaching the
Endcap as this indicates correct attachment.
NOTE: Ensure that the secondary working channel
is not obstructed on the Endoscope.
WARNING: Ensure Endcap is fully seated on
Endoscope.
4.5. Assemble Needle Driver handle onto Endoscope.
NOTE: Ensure external cable is not twisted around
Endoscope.
4.6. Connect Endoscope to Tower.
Load Anchor
4.7. Select appropriate Suture type / size.
4.8. Remove Suture Assembly and Anchor Exchange
from packaging.
4.9. Load the Anchor.
4.10. Remove Suture from Suture Cartridge by holding
and pulling the Suture, not the Anchor or Anchor
Exchange.
NOTE: Ensure Suture is not tangled after removal
from the cartridge.
4.11. Open valve cover and insert Anchor Exchange into
primary channel of Endoscope.
CAUTION: Do not use when valve covers are closed
as suture drag will be increased.
4.12. Using a ‘pencil-grip’ on the catheter for optimum
control, advance Anchor Exchange until Anchor is
positioned near distal end of Endoscope.
CAUTION: If resistance is encountered when
advancing the Anchor Exchange through the
working channel of the Endoscope, reduce the
Endoscope angulation until the device passes
smoothly.
4.13. Insert Endoscope into patient.
WARNING: Do not introduce the device with the
Needle Body in its open position.
5. Navigating to target anatomy
5.1. Advance until target anatomy is located.
CAUTION: When intubating or extubating with
the Endoscopic Suturing System, ensure that the
working length of the Endoscope and the actuation
catheter are advanced and retracted together.
5.2. Open Needle Body.
5.3. Advance Anchor Exchange and/or manipulate
Endoscope to create Suture slack.
5.4. Once sufcient slack has been created, retract
Anchor Exchange into the Endoscope.
5.5. Close Needle Body.
5.6. Use a ‘pencil-grip’ on the white portion of the cable
to advance Anchor Exchange until Anchor fully seats
onto Needle Body.
‘click’
5.7. A tactile ‘click’ or rm stop may be felt as the
Anchor seats fully onto Needle Body.
5.8. Check the monitor image to ensure Anchor is
properly installed on Needle Body.
5.9. Ensure that the proximal end of the Suture is visible
beyond the Endoscope channel valves.
5.10. Fully depress Anchor Release Button to release
Anchor.
5.11. With Anchor Release Button still fully depressed,
slightly retract Anchor Exchange.
‘hold’
6. Tissue and Suture Management
6.1. Open Needle Body.
CAUTION: If the Needle Body does not open,
ensure that the Anchor has been released from the
Anchor Exchange.
WARNING: Ensure appropriate Suture slack
has been created for desired Suture path and
pattern. Advance Anchor Exchange and/or
manipulate Endoscope to create Suture slack.
6.2. Position tissue in appropriate location for suturing,
using Apollo Helix or Endoscope compatible
accessory if required.
7. Use ofTissue Helix (Optional)
7.1. Advance Helix into secondary channel of Endoscope
in the retracted position, until distal tip is visible on
the monitor.
CAUTION: If resistance is encountered when
advancing the Helix through the working channel of
the Endoscope, reduce the Endoscope angulation
until the device passes smoothly, and ensure that
the secondary working channel is not obstructed on
the Endoscope.
7.2. Fully depress Helix Handle button to expose Helix Tip.
CAUTION: Do not depress Helix Handle button
while advancing Helix through Endoscope.

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7.3. Acquire tissue by rotating Helix Handle clockwise
until correct tissue depth is achieved.
7.4. Maintain gentle forward pressure during tissue
acquisition.
7.5. Advance / retract Helix to position tissue into
desired location.
8. Suturing
8.1. Drive Needle through tissue by closing the Needle
Body.
8.2. Ensure that the Needle Arm does not inadvertently
close on any foreign object or device.
Retrieve Anchor
8.3. Use a ‘pencil-grip’ to advance the Anchor Exchange
until the Anchor is engaged and resistance is felt.
‘click’
NOTE: Resistance may vary due to the position of
the Endoscope.
8.4. Retract Anchor Exchange to acquire Anchor.
‘pop’
8.5. Use a ‘pencil-grip’ on the white section of the cable
and place the remaining ngers of the same hand
on the Endoscope housing to prevent damage to
Suture or tissue once the Anchor ‘pops’ off the
Needle Body.
CAUTION: Do not press the Anchor Release Button,
as this may cause inadvertant drop of the Anchor.
WARNING: If sufficient slack has not been
created prior to driving the Anchor through
tissue, retraction of the Anchor Exchange may be
difficult and the Anchor may not release correctly
from the Needle Body.
ReleaseTissue
8.6. Rotate Helix handle counter-clockwise until the
device is free from tissue.
8.7. Return the Helix handle button.
8.8. Check monitor to ensure tip is fully retracted into
shaft before withdrawing into Endoscope.
8.9. Withdraw Helix a short distance into Endoscope.
8.10. Open Needle Body.
CAUTION: Do not tension the Suture with the
Anchor in the Needle Body.
8.11. To continue placing stitches with this Anchor,
repeat sections 5-8.
If stitching is complete for this Anchor, proceed to
section 9 to approximate tissue, secure and cut the
Suture.
Multiple Anchors can be utilized with each Needle
Driver and Anchor Exchange.
9. Securing and Cutting Suture
9.1. Remove accessories (Apollo Helix or similar) from
Endoscope.
9.2. Ensure Anchor is in Anchor Exchange and open
Needle Body.
9.3. Advance Anchor distal of the alignment tube.
9.4. Fully depress Anchor Release Button and retract
Anchor Exchange to release Anchor.
CAUTION: Do not release the Anchor inside the
Endoscope’s working channel.
9.5. Remove Anchor Exchange from Endoscope.
NOTE: The Anchor Exchange can be utilized for
additional sutures.
9.6. Feed proximal end of Suture into removable Suture
Loading Loop.
9.7. After threading, release the proximal end of the
Suture to enable loading.
9.8. Pull Suture Loading Loop parallel to the device, to
pull Suture into Cinch.
9.9. Holding the proximal end of the Suture, feed the
Cinch down the working channel until ‘Plug and
Collar’ can be seen on the monitor.
9.10. Pull the Suture and apply counter traction to the
Cinch until the tissue is approximated and the
desired Suture tension is achieved between the
Anchor and the Cinch Collar.
NOTE: It is the Collar that sets the nal position of
the Cinch, not the Plug.
WARNING: Excessive tension may damage
tissue.
9.11. Remove safety spacer from Cinch handle.
CAUTION: The safety spacer must only be removed
immediately prior to deploying Cinch.
9.12. Firmly squeeze Cinch Handle to deploy Cinch and
cut Suture.
CAUTION: Suture tension must be maintained.
NOTE: Signicant force is required to pull and lock
the Plug into the Collar, a ‘pop’ can often be felt
once the Suture is cut.
9.13. Remove the Cinch.
9.14. Close Needle Body.
10. Multiple Sutures
10.1. Anchor Exchange and Needle Driver can be utilized
with multiple sutures. Removal of the Endoscope
after cinching is not required if further sutures are
to be deployed.
WARNING: If the Endoscope is removed
between stitching for cleaning, ensure the
Endcap is fully seated before next intubation.
Reseat if necessary.
NOTE: If removed and reinstalled, ensure that the
secondary working channel is not obstructed on the
Endoscope.
10.2. To use another Suture Assembly, return to step 4.7
for Anchor loading and follow all subsequent steps.
If suturing is complete, proceed to section 11 for
removal of the device.
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11. Removal of Device
11.1 Remove any accessory devices from Endoscope.
11.2. Ensure the Needle Body is closed and retract
Endoscope from patient, making sure the external
cable is retracted together with the Endoscope.
11.3. Remove Endcap from Endoscope.
NOTE: Do not hold Needle Arm to remove the
Endcap.
11.4. Remove Needle Driver from Endoscope by exing
the scope attachment bracket around the working
channels.
12. MRI Safety Information
MR Conditional
MR
Non-clinical testing has demonstrated that the Sutures,
Cinches and Anchors (collectively termed Anchoring
System) deployed by the OverStitch Endoscopic Suturing
System are MR Conditional.
A patient with this Anchoring System can be safely
scanned immediately after placement in an MR system
meeting the following conditions:
Static Magnetic Field
- Static magnetic eld of 1.5 T or 3.0 T.
- Maximum spatial eld gradient of 2,000 gauss/cm
(20 T/m).
- Maximum MR system reported, whole body averaged
specic absorption rate (SAR) of 2 W/kg.
Under the scan conditions dened above, the
Anchoring System is expected to produce a maximum
temperature rise of less than 2º C after 15 minutes of
continuous scanning.
In non-clinical testing, the image artifact caused by the
Anchoring System extends approximately 10 mm from
this device when imaged with a gradient echo pulse
sequence and a 3.0 T MRI system.
13. Hazardous Substance Information
Contains Hazardous Substance
CMR Statement – The stainless steel and cobalt alloy
components within this device contain the following
substance(s) defined as a CMR (carcinogenic, mutagenic
or toxic to reproduction) 1A/1B and/or endocrine
disrupting in a concentration above 0.1% weight by
weight:
Cobalt (CAS No. 7740-48-8; EC No. 231-158-0)
Current scientific evidence supports medical devices
manufactured from these cobalt alloys or stainless steels
containing cobalt do not cause increased risk of cancer or
adverse reproductive effects.
14. Troubleshooting
14.1. Needle Body will not open:
Cause Resolution
14.1.1. Needle obstructed: i. Assess the space in which you are working and maneuver the catheter and Endoscope as a system, straighten
the Endoscope to the non-Retroexed position.
14.1.2. Suture movement restricted:
i. If the Anchor is on the Needle Body, ensure the suture is not held proximally near the handle during the opening
operation.
ii. Transfer the Anchor to the Anchor Exchange. Open the Needle Body. Slowly retract the Anchor Exchange
proximally and then advance the Needle Body distally to free the Suture.
14.1.3. Needle Driver catheter looped or kinked:
i. Check to ensure that the catheter running down the outside of the Endoscope is not looped or kinked. Straighten
the Endoscope to the non-Retroexed position. Advance the Endoscope forward and slightly pull any slack from the
actuation catheter proximally until minimal resistance is felt. Grasp both the actuation catheter and Endoscope and
adjust by advancing and retracting as a system.
14.1.4. Foreign body obstruction:
i. Remove the Anchor Exchange only:
a. Transfer the Anchor to the Needle Body and remove the Anchor Exchange from the Endoscope.
b. Load a grasper through the primary channel and push the Needle Body open.
ii. Remove the Anchor and Anchor Exchange, cutting the Suture if necessary:
a. Transfer the Anchor to the Needle Body and remove the Anchor Exchange from the Endoscope.
b. Through either channel use an appropriate accessory to cut the Suture.
c. Use an accessory to push open the Needle Body
d. Use appropriate means to remove the cut Suture.
iii. Once standard endoscopic techniques have been exhausted, utilize laparoscopic techniques to remove the
device.
14.2. Needle Body will not close:
Cause Resolution
14.2.1. General obstruction:
i. Follow steps 14.1.1, 14.1.2, 14.1.3 above (Needle Body will not open).
ii. Ensure the Needle Driver handle is locked closed and:
a. Stretch the Needle Driver catheter to change the effective length of the Needle Body drive cable.
b. Remove the Anchor Exchange and use graspers (through the primary channel) to grab the Needle Body. Cut the
Suture if necessary.
14.2.2. Needle Driver cable broken:
i. Deploy the Anchor and Cinch. Advance grasper through endoscope and secure Needle Driver. Pull Needle Driver
closed while removing the device. If using an overtube, advance the overtube as far distally as possible and withdraw
the endoscope and device into the overtube, using the distal tip of the overtube to close the Needle Body.
14.3. Anchor Exchange will not exchange:
Cause Resolution
14.3.1. Anchor Exchange will not install Anchor onto the
Needle Body:
i. Ensure there is sufcient Suture slack and the Suture outside Endoscope is not entangled.
ii. Ensure Anchor Exchange is properly positioned in alignment tube of Needle Driver.
iii. If Anchor and Suture are through tissue, either drop Anchor and deploy Cinch per Section 9 of Instructions for
Use or drop Anchor and use a suitable accessory to cut and remove the Suture.
iv. If Anchor and Suture are not through tissue, close handle of Needle Driver. Remove Endoscope. Replace Anchor
and/or Anchor Exchange.
14.3.2. Anchor Exchange will not release an Anchor: i. Ensure there is sufcient Suture slack and the Suture outside Endoscope is not entangled.
ii. Ensure the Anchor Exchange Release Button is FULLY depressed while retracting Anchor Exchange.
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Cause Resolution
iii. Reduce the articulation / tortuosity of the Endoscope (if possible) and try to release the Anchor.
iv. Use accessories compatible with Endoscope secondary working channel to cut and remove the Suture.
v. Replace the Anchor Exchange.
14.3.3. Anchor Exchange will not retrieve Anchor from Needle
Body:
i. Ensure there is sufcient Suture slack and Needle Driver handle is in closed position.
ii. Use ‘pencil-grip’ to advance Anchor Exchange until the Anchor is engaged and resistance is felt. Retract Anchor
Exchange to acquire Anchor.
iii. If the Anchor cannot be retrieved, replace the Anchor Exchange. Alternatively, use a suitable accessory to cut
and remove the Suture.
iv. Replace the Anchor and resume suturing per Section 8 of Instructions for Use.
14.4. Cinch does not cut the Suture when fired:
Cause Resolution
14.4.1. Suture not cut: i. Use a suitable accessory through the secondary working channel to cut the Suture and remove the Cinch.
ii. Use standard endoscopic techniques to remove the cut Suture.
14.5. Inadvertent drop of Anchor:
Cause Resolution
14.5.1. Anchor Exchange button depressed out of sequence:
i. Retrieve the Anchor as a foreign body, or follow the procedure to Cinch in place. If the Anchor is dropped inside
the working channel, use the Anchor Exchange or 3.2 mm compatible grapser to push the Anchor out through the
Endoscope.
Do not attempt to pull the Anchor back through the Endoscope as it may get stuck in the channel or y-junction at
the Endoscope handle.
14.6. Suture entanglement:
Cause Resolution
14.6.1. Suture outside eld of view: i. Close the Needle Driver Handle and manipulate the Endoscope back to release.
14.6.2. Suture behind Tissue Guard:
i. Slightly close the Needle Body while retracting the Endoscope.
ii. If necessary, transfer the Anchor to the Anchor Exchange.
iii. Open the Needle Body and advance the Anchor Exchange beyond the Endcap to push the Suture free.
14.6.3. Suture twisted:
i. If the Suture is twisted, move the Endoscope and transfer the Anchor between the Needle Body and Anchor
Exchange, on the opposite side of the suture thread, as needed to untwist.
NOTE: If the twist was noted immediately after articulation of the Endoscope, rst try to articulate in reverse order
to remove.
ii. If the Anchor has been deployed, use the Cinch to push and guide the Suture free.
14.7. Endcap detachment from Endoscope:
Cause Resolution
14.7.1. Pushed off during use:
i. Close the Needle Body. Using a rat-toothed grasper, capture the alignment tube “zigzag” cutout and remove
any slack in the Actuation Catheter and slowly remove the device from the patient. If using an overtube, using a
rat-toothed grasper, capture the alignment tube “zigzag” cutout and remove any slack in the Actuation Catheter and
slowly remove the device from the patient.
14.8. Helix does not unscrew:
Cause Resolution
14.8.1. Helix stuck in tissue:
i. Use a suitable accessory through the primary channel to apply counter traction to the tissue around the Helix, and
pull the Helix free.
ii. Once endoscopic techniques have been exhausted, utilize laparoscopic techniques to remove the Helix.
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8
Tabla de símbolos
Para un solo uso. Desechable. No reesterilizar.
Precaución: La ley federal de EE. UU. restringe laventade este dispositivo a médicos o por prescripción facultativa.
Patente en trámite.
EXENCIÓN DE GARANTÍAY LIMITACIÓN DE RECURSOS
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Descripción Símbolo Descripción Símbolo Descripción Símbolo
Consultar las Instrucciones de uso Fabricante Fecha de caducidad
No reutilizar
Precaución: La ley federal de EE. UU.
restringe la venta de este dispositivo
a médicos o por prescripción facultativa
Número de lote
Esterilizado con óxido de etileno Fecha de fabricación No utilizar si el envase está dañado
Número de referencia No reesterilizar Representante autorizado en la
Comunidad Europea
Producto sanitario Contiene una sustancia peligrosa
1. Uso indicado
El sistema de sutura endoscópica (SSE) OverStitch™ de Apollo Endosurgery está
indicado para la colocación endoscópica de una o más suturas y para la aproximación
de tejido blando.
1.1 Contraindicaciones
Entre las contraindicaciones se cuentan aquellas especícas del uso de un sistema de
sutura endoscópica y de cualquier tipo de procedimiento endoscópico, y pueden incluir,
entre otras, las siguientes:
• Este sistema no debe utilizarse cuando las técnicas endoscópicas
estén contrindicadas.
• Este sistema no debe utilizarse con tejido maligno.
1.2 Advertencias
• No utilice el dispositivo si la integridad del envase estéril se ha visto afectada o si el
dispositivo parece dañado.
• Solo médicos con el suciente conocimiento y experiencia en estas mismas
técnicas o en otras parecidas deberían realizar procedimientos endoscópicos.
• El contacto de los componentes electroquirúrgicos con otros componentes
puede ocasionar lesiones al paciente o al cirujano, así como daño al dispositivo
o al endoscopio.
• Verique la compatibilidad de los instrumentos y accesorios endoscópicos,
y asegúrese de que el rendimiento no se vea afectado.
NOTA: Los endoscopios reacondicionados pueden dejar de cumplir las
especificaciones originales.
• Compruebe que haya suciente espacio para que la aguja se abra.
• Compruebe que el agarre del mango del sistema de sutura endoscópica esté
cerrado y bloqueado durante la intubación y la extubación.
• Los usuarios deberán estar familiarizados con los procedimientos y técnicas
quirúrgicas que utilizan suturas absorbibles antes de emplear suturas sintéticas
absorbibles para el cierre de las heridas, ya que el riesgo de dehiscencia de la
herida puede variar con el sitio de aplicación y el material de sutura usado.
• La reutilización o el reprocesamiento del sistema OverStitch podría hacer que el
sistema funcione incorrectamente o que el paciente sufra consecuencias, lo que
incluye:
–Infección o transmisión de enfermedades.
–Fallo del mecanismo del mango que haga que el dispositivo quede
bloqueado sobre el tejido y sea necesaria una intervención quirúrgica.
–Reducción de la retención sobre el endoscopio que haga que el mecanismo
de cierre terminal se desprenda durante el uso y sea necesaria una
intervención quirúrgica para recuperarlo.
–Reducción de la retención del anclaje al cuerpo de la aguja, lo que puede
provocar una caída inadvertida del anclaje que cause una demora del
procedimiento o requiera intervención posterior.
–Doblamiento del cuerpo de la aguja, lo que puede impedir que el médico
conduzca la aguja correctamente o realice el procedimiento deseado.
–Imposibilidad de extender totalmente la hélice, lo que puede limitar la
capacidad para obtener tejido y realizar el procedimiento deseado.
• Si el dispositivo mencionado se utiliza para sobresuturar cuerpos extraños, como
grapas, endoprótesis, clips o mallas, es posible que la aguja se quede atrapada en
el cuerpo extraño, lo que requeriría una intervención quirúrgica.
• En las situaciones en las que el sitio quirúrgico represente un riesgo de daños
a las estructuras anatómicas adyacentes, se recomienda el uso de accesorios
endoscópicos como la hélice para tejido OverStitch, que permite retraer el tejido
que se pretende suturar y apartarlo de estas estructuras no visibles.
1.3 Precauciones
• El sistema solo puede utilizarse si ha sido comprado directamente de Apollo
Endosurgery, Inc. o de uno de sus agentes autorizados.
• Con el sistema de sutura endoscópica instalado, el canal principal del endoscopio
se convierte de hecho en un canal de 3,2 mm.
• Se puede utilizar un tubo de inserción con un diámetro interno de al menos
16,7mm con el sistema para proteger el esófago.
1.4 Compatibilidad del sistema
El sistema de sutura endoscópica OverStitch es compatible con las suturas identificadas
en la página 1.
OverStitch es compatible con los siguientes endoscopios:
• Olympus 2T160, 2TH180 o 2T240
• Fuji EI-740D/S
La disponibilidad de dispositivos compatibles puede variar según la región.
1.5 Posibles eventos adversos
Las posibles complicaciones que pueden resultar del uso del sistema de sutura
endoscópica incluyen, entre otras:
• Faringitis/dolor de garganta
• Náuseas o vómitos
• Dolor abdominal o hinchazón
• Hemorragia
• Hematoma
• Conversión a procedimiento laparoscópico o abierto
• Estenosis
• Infección/sepsis
• Perforación faríngea, colónica o esofágica
• Laceración esofágica, colónica o faríngea
• Lesión visceral intrabdominal (hueca o sólida)
• Aspiración
• Dehiscencia de la herida
• Reacción tisular inflamatoria aguda
• Muerte
NOTA: Todo incidente grave que se haya producido en relación con el producto deberá
notificarse a Apollo Endosurgery (consulte la información de contacto al final de este
documento), así como a las autoridades oficiales pertinentes.
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2. Sistema envasado
Accionador de la aguja y
dispositivo de cambio de anclaje
Envase 1
Envase 2
{ }
Conjunto de sutura
Envase 3 Envase 4
Polidioxanona (absorbible) –
VIOLETA
Polipropileno (no absorbible) – AZUL
Hélice
(DISPONIBLE POR SEPARADO)
Guía tensora
3. Nomenclatura
Endoscopio
Accionador de la aguja
Mecanismo de
cierre terminal
Dispositivo de cambio del anclaje
Botón de liberación del
anclaje
Mango del
accionador
de la aguja
Mango del
endoscopio
Conjunto de sutura
Cuerpo del anclaje
Sutura
Punta helicoidal
Hélice
Mango de la hélice
Guía tensora
Mango de la guía
tensora
Anillo Tapón
Lazo de carga de la sutura
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4. Montaje
4.1. Coloque el endoscopio compatible en una supercie
adecuada para el montaje.
NOTA: Asegúrese de que se hayan instalado
las válvulas de canal estándares en los canales
de trabajo.
4.2. Extraiga el accionador de la aguja del envase.
4.3. Cierre el cuerpo de la aguja.
‘clic’
NOTA: Asegúrese de que el mecanismo de cierre
terminal no se caiga ni se dañe de ninguna otra
forma.
4.4. Empuje el tubo de alineación para introducirlo en el
canal de trabajo principal hasta que el mecanismo
de cierre terminal esté enrasado con la cara del
endoscopio.
NOTA: Deberá sentirse resistencia al conectar el
mecanismo de cierre terminal ya que esto indica
una conexión correcta.
NOTA: Asegúrese de que el canal de trabajo
secundario no esté obstruido en el endoscopio.
ADVERTENCIA: Asegúrese de que el mecanismo
de cierre terminal esté totalmente asentado en el
endoscopio.
4.5. Monte el mango del accionador de la aguja sobre
el endoscopio.
NOTA: Asegúrese de que el cable externo no esté
enrollado alrededor del endoscopio.
4.6. Conecte el endoscopio a la torre.
Cargue el anclaje
4.7. Seleccione el tipo y tamaño de sutura adecuados.
4.8. Extraiga el conjunto de la sutura y el dispositivo de
cambio del anclaje del envase.
4.9. Cargue el anclaje.
4.10. Extraiga la sutura del cartucho de la sutura sujetando
y tirando de esta última, no del anclaje ni del
dispositivo de cambio del anclaje.
NOTA: Tras extraer la sutura del cartucho,
compruebe que no esté enredada.
4.11. Abra la cubierta de la válvula e inserte el dispositivo
de cambio del anclaje en el canal principal del
endoscopio.
PRECAUCIÓN: No lo utilice cuando las cubiertas
de las válvulas estén cerradas ya que aumentará la
resistencia de la sutura.
4.12. Sujetando el catéter con la mano como si fuera un
lápiz para lograr un control óptimo, haga avanzar
el dispositivo de cambio del anclaje hasta que el
anclaje esté situado cerca del extremo distal del
endoscopio.
PRECAUCIÓN: Si se encuentra resistencia al hacer
avanzar el dispositivo de cambio del anclaje a través
del canal de trabajo del endoscopio, reduzca la
angulación de este último hasta que el dispositivo
pase sin atorarse.
4.13. Introduzca el endoscopio en el paciente.
ADVERTENCIA: No introduzca el dispositivo con
el cuerpo de la aguja en su posición abierta.
5. Desplazamiento a la diana anatómica
5.1. Avance hasta que se localice la diana anatómica.
PRECAUCIÓN: Durante la intubación o extubación
con el sistema de sutura endoscópica, asegúrese
de que el catéter accionador y el endoscopio (su
longitud de trabajo) se hagan avanzar y se retraigan
juntos.
5.2. Abra el cuerpo de la aguja.
5.3. Haga avanzar el dispositivo de cambio del anclaje
o manipule el endoscopio para crear holgura en la
sutura.
5.4. Una vez que se haya creado la suciente holgura,
retraiga el dispositivo de cambio del anclaje al
interior del endoscopio.
5.5. Cierre el cuerpo de la aguja.
5.6. Sujete el tramo blanco del cable con la mano como
si fuera un lápiz para hacer avanzar el dispositivo
de cambio del anclaje hasta que el anclaje esté
totalmente asentado sobre el cuerpo de la aguja.
‘click’
5.7. Es posible que se perciba un ‘clic’ táctil o una
parada rme en el momento en que el anclaje se
asienta completamente sobre el cuerpo de la aguja.
5.8. Compruebe la imagen del monitor para garantizar
que el anclaje esté bien instalado sobre el cuerpo de
la aguja.
5.9. Asegúrese de que el extremo proximal de la sutura
esté visible más allá de las válvulas de los canales
del endoscopio.
5.10. Presione a fondo el botón de liberación del anclaje
para liberar el anclaje.
5.11. Sin soltar el botón de liberación del anclaje, retraiga
ligeramente el dispositivo de cambio del anclaje.
‘hold’
6. Manejo del tejido y de la sutura
6.1. Abra el cuerpo de la aguja.
PRECAUCIÓN: Si el cuerpo de la aguja no se abre,
compruebe que el anclaje se haya liberado del
dispositivo de cambio del anclaje.
ADVERTENCIA: Asegúrese de que la holgura de
la sutura que se hacreado sea suficiente para el
trayecto y el patrón de sutura deseados. Haga
avanzar el dispositivo decambio del anclaje o
manipule el endoscopio para crear más holgura
para la sutura.
6.2. Coloque el tejido en el lugar adecuado para
suturarlo, usando la hélice Apollo o un accesorio
compatible con el endoscopio si se requiere.
7. Uso de la hélice para tejido (opcional)
7.1. Haga avanzar la hélice al interior del canal
secundario del endoscopio en la posición retraída,
hasta que la punta distal esté visible en el monitor.
‘clic’
‘retener’
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