Ethicon endo-surgery Contour cs40b User manual

Please read all information carefully.

Failure to properly follow the instructions may lead to serious surgical consequences, such as leakage or

disruption.

Important: This package insert is designed to provide instructions for use of the CONTOUR®Curved Cutter

Stapler and Reloads. It is not a reference to surgical stapling techniques.

CONTOUR is a trademark of Ethicon Endo-Surgery.

Curved Cutter Stapler and Reloads

Agrafeuse coupante courbe et chargeurs

Curved Cutter Stapler und Magazine

Suturatrice taglia e cuci curva e ricarica

Agrafador cortador curvo e recargas

Grapadora cortadora curva y cargas

Stapler met gebogen cutter en vullingen

Buet skærende stapler og ekstra magasiner

Kaareva leikkuri-nitoja ja vaihto-osat

Κυρτός κοπτοράπτης και ανταλλακτικά φυσίγγια

Böjd kniv/suturmaskin och omladdningar

Zakrzywiony stapler tnący i magazynki

Hajlított vágótűzőgép és utántöltők

Zakřivenýdisekční stapler s náhradními náplněmi

Zakrivená rezacia zošívačka a nábojnice

弧形切割吻合器和钉仓

4 5

Indications

The CONTOUR Curved Cutter Stapler is intended for transection, resection, and/or creation of anastomoses.

The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal

muscle), gynecologic, urologic, and thoracic surgical procedures.

Contraindications

• This instrument is not intended for use when surgical stapling is contraindicated.

• Do not use the instrument with blue reload on any tissue that requires excessive force to compress

to 1.5 mm or on any tissue that compresses easily to below 1.5 mm.

• Do not use the instrument with green reload on any tissue that requires excessive force to compress

to 2.0 mm or on any tissue that compresses easily to below 2.0 mm.

• Do not use on ischemic or necrotic tissue.

• Do not use on major vessels without provision for proximal and distal control.

• Do not use the instruments on any portion of the aorta, the coronary, carotid, or pulmonary arteries or

veins, the superior or inferior vena cava, common, internal or external iliac arteries and veins and the

brachiocephalic trunk.

• Do not use the instrument on the vaginal cuff.

Device Description

The CONTOUR Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts

and staples. The device delivers four staggered rows of titanium staples, with a knife between the second

and third row of staples, and creates a 40 mm curved transection. The device is designed with a feature

which prevents closing if a used reload or no reload is in the instrument. Another feature is provided to

prevent firing unless the closure trigger is latched in the closed position. A retaining pin holds tissue in place

and can be positioned either manually or by squeezing the closure trigger.

The instrument may be reloaded five times, for a maximum of six firings per instrument during a single

procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on each

side, an anvil, a cutting washer, a retaining pin, and a staple retainer. Reload cartridges are available in two

sizes. Refer to the table below.

The product codes for the CONTOUR Curved Cutter Stapler and reloads are as follows:

Instrument Reload Description Number Reload Tissue

of Staples Color Thickness

CS40B CR40B Standard 46 Blue 1.5 mm

CS40G CR40G Thick 46 Green 2.0 mm

NOTE: The blue (standard) and green (thick) reloads can be used interchangeably with the instruments.

Illustration and Nomenclature (Illustration 1)

1. Curved Head 7. Handle

2. Cartridge Module 8. Closure Trigger

3. Retaining Pin 9. Firing Trigger

4. Push Rod 10. Cartridge Module

5. Retaining Pin Actuator 11. Cartridge Anvil

6. Release Button 12. Staple Retainer

General Instructions for Use

Verify compatibility of all instruments and accessories prior to using the instrument.

(Refer to Warnings and Precautions.)

1Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the

instrument into the sterile field.

2Remove the staple retainer from the instrument by pushing on the pad labeled “Push to Remove”.

(Illustration 2). Hold the cartridge when removing the retainer. Check that the cartridge is fully

loaded into the instrument (press down) after the retainer has been removed. Discard the staple

retainer.

3Grasp the instrument handle in the palm of the hand with the fingers around the closure trigger.

Position tissue to be cut and stapled between the anvil and the cartridge.

NOTE: Any tissue covering the hole in the anvil will be pierced by the retaining pin. Reposition the

tissue if necessary.

4Either manually advance the retaining pin using the actuator button on top of the handle to capture

the tissue within the jaw opening (Illustration 3A), or automatically advance the retaining pin by

squeezing the closure trigger (Illustration 3B). Note that there is an audible click halfway through the

closure stroke indicating that the device is in the intermediate position. In the intermediate position,

the pin is fully seated in the anvil capturing the tissue, and the jaws are partially open. Reposition

tissue within the instrument if desired. The closure trigger can be released at this point, and the

instrument will maintain its jaw opening to allow for final positioning of the tissue to be cut and

stapled. The retaining pin is fully engaged.

Caution: Make sure tissue to be stapled is properly positioned in the jaws before stapling. Bunching,

stretching or uneven loading of tissue could result in leakage, lack of hemostasis, or disruption of

staple line.

NOTE: If using the automatic advancement of the retaining pin, ensure that the tissue is correctly

placed to avoid accidental piercing of tissue.

NOTE: Do not grasp the firing trigger before the instrument is to be fired.

NOTE: Recommended operation is to manually advance the Retaining Pin.

5Squeeze the closure trigger and handle together until the closure trigger is latched. Listen for an

audible click. When the closure trigger is latched, the firing trigger moves to the ready-to-fire position

(Illustration 4). The cartridge has clamped onto the tissue which is ready to be cut and stapled. Ensure

that the closing stroke is completed. All fingers should be completely removed from the closing trigger

to ensure that the closing system holds.

NOTE: If the tissue needs to be repositioned within the instrument before stapling, open the jaws by

squeezing the handle and closure trigger together slightly, push the release button, and slowly release

grasp of the closure trigger. The closure trigger will return to the fully open position and the jaws will

release the tissue but the retaining pin will remain extended. Tissue can now be repositioned.

NOTE: The CONTOUR Curved Cutter Stapler is designed with a feature which allows partial closing

if a used reload, no reload, or an incorrectly inserted reload is in the instrument. In these cases, the

device will close approximately one-third of the stroke and stop, but will return to the full open

position when the closure trigger is released. The used or misloaded cartridge module should then

be replaced with a new reload or, if no cartridge was present, a cartridge should be loaded in the

instrument. After following the above steps, any device which does not close either partially or

completely should not be used.

NOTE: After closing, pausing for 15 seconds prior to firing may result in better tissue compression

and better staple form.

NOTE: If closure trigger (1) is difficult to lock, reposition the instrument and take a smaller amount of

tissue. (See Contraindications for appropriate reload selection).

6With the handle and closure trigger grasped in the palm of the hand, place all fingers around the

firing trigger. Before firing, check to ensure the retaining pin is seated in the anvil.

Caution: Always ensure complete closing prior to firing.

Caution: Before firing, verify that the intended tissue is in the closed jaws of the instrument. If the pin

is not properly positioned, staples may not form properly, which may result in leakage or disruption of

the staple line.

Caution: When positioning the stapler on the application site, ensure that no obstructions such as

clips, stents, guide wires, etc., are incorporated into the instrument jaws. Firing over an obstruction

may result in incomplete cutting action and/or improperly formed staples.

Caution: Care should be taken not to fire this instrument when the resulting staple line will be in

tension.

7Completely fire the instrument by squeezing the firing trigger until it touches the closure trigger

(plastic to plastic), signifying that the instrument has fired the staples and knife blade, and the tissue

has been transected. (Illustration 5) The firing trigger automatically returns to the intermediate

position as soon as the hand releases it, leaving the closure trigger in the fully closed position. Make

sure that the release button is not pressed during firing as proper formation of staples and cut line

may be compromised.

Caution: Attempting to force the trigger to complete the closing stroke with too much

tissue or thickened tissue may result in poor staple line integrity with possible leakage or disruption.

In addition, instrument damage or failure may result.

Caution: The firing stroke must be completed. Do not partially fire the instrument. Incomplete firing

can result in malformed staples, incomplete cut line, bleeding, and leakage from the staple line and/or

difficulty removing the device.

8After firing the instrument, open the jaws of the instrument by squeezing the closure trigger and

pushing the release button with the thumb. For controlled release, while holding the release button

down, open your hand to release the closure trigger. (Illustration 6) The cartridge drivers are exposed

as a spent cartridge indicator. If the instrument becomes locked onto tissue and will not open by

pressing the release button, the device can be opened by depressing the release button and pulling the

closure trigger simultaneously.

Caution: Examine the staple line for hemostasis and proper staple formation. If hemostasis is not

present, appropriate techniques should be used to achieve hemostasis.

Caution: Following a division of the rectum, it is recommended that a leak test is performed prior to

the creation of the anastomosis.

9Retract the retaining pin manually. Ensure that the staple line and the cut line are complete. Remove

the instrument. (Illustration 7)

Muscle Stapling Instructions for Use

Verify compatibility of all instruments and accessories prior to using the instrument.

(Refer to Warnings and Precautions.)

1Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the

instrument into the sterile field.

2Remove the staple retainer from the instrument by pushing on the pad labeled “Push to Remove”.

(Illustration 2). Hold the cartridge when removing the retainer. Check that the cartridge is fully

loaded into the instrument (press down) after the retainer has been removed. Discard the staple

retainer.

3Grasp the instrument handle in the palm of the hand with the fingers around the closure trigger.

Position tissue to be cut and stapled between the anvil and the cartridge.

NOTE: Any tissue covering the hole in the anvil will be pierced by the retaining pin. Reposition the

tissue if necessary.

4Recommended operation, in skeletal muscle, is to manually advance the Push Rod using the

Retaining Pin Actuator. Squeeze the closure trigger (Illustration 3B). Note that there is an audible

click halfway through the closure stroke indicating that the device is in the intermediate position.

In the intermediate position, the pin is fully seated in the anvil capturing the tissue, and the jaws are

partially open. Reposition tissue within the instrument if desired. The closure trigger can be released

at this point, and the instrument will maintain its jaw opening to allow for final positioning of the

tissue to be cut and stapled. The retaining pin is fully engaged.

Caution: Make sure tissue to be stapled is properly positioned in the jaws before closing the jaws

or stapling. Bunching, tension, stretching or uneven loading of tissue could result in leakage, lack of

hemostasis, or disruption of staple line.

NOTE: In thick skeletal muscle tissue, two approaches are recommended for device closure:

• A single slow, controlled and continuous squeeze of the Closure Trigger

• Progressively squeezing and relaxing (pumping) the Closure Trigger

NOTE: Do not grasp the firing trigger before the instrument is to be fired.

5Squeeze the closure trigger and handle together until the closure trigger is latched. Listen for an

audible click. When the closure trigger is latched, the firing trigger moves to the ready-to-fire

position (Illustration 4). The cartridge is clamped onto the tissue, which is ready to be stapled and

cut. Ensure that the closing stroke is completed. All fingers should be completely removed from the

closing trigger to ensure that the closing system holds.

NOTE: If the closure trigger is difficult to lock, reposition the instrument and take a smaller amount

of tissue.

NOTE: Do not use excessive force to close the instrument. Forcing the instrument to fully close, with

excess tissue, may result in the closure trigger breaking.

NOTE: If the tissue needs to be repositioned within the instrument before stapling, open the jaws by

squeezing the handle and closure trigger together slightly, push the release button, and slowly release

grasp of the closure trigger. The closure trigger will return to the fully open position and the jaws

will release the tissue but the retaining pin will remain extended. Tissue can now be repositioned.

NOTE: The muscle stapling CONTOUR Curved Cutter Stapler is designed with a feature that allows

partial closing if a used cartridge reload, no cartridge reload, or an incorrectly inserted cartridge

reload is in the instrument. In these cases, the device will close approximately one-third of the stroke

and stop, but will return to the full open position when the closure trigger is released. The used or

misloaded cartridge module should then be replaced with a new cartridge reload or, if no cartridge

was present, a cartridge should be loaded in the instrument. After following the above steps, any

device that does not close either partially or completely should not be used.

NOTE: After closing, pausing for 15 seconds prior to firing may result in better tissue compression

and better staple form.

6 With the handle and closure trigger grasped in the palm of the hand, place all fingers around the

firing trigger. Before firing, check to ensure the retaining pin is seated in the anvil.

Caution: Always ensure complete jaw closure prior to firing.

Caution: Before firing, verify that the intended tissue is in the closed jaws of the instrument. If

the pin is not properly positioned, staples may not form properly, which may result in leakage or

disruption of the staple line.