Devicor Mammotome elite 10G User manual

Please read all information carefully.
Failure to properly follow the instructions may lead to serious surgical consequences.
IMPORTANT: This package insert is designed to provide instructions for use of the
Mammotome elite® Introducer Stylet. It is not a reference to surgical techniques.
Refer to the Mammotome elite® Holster and Probe Instructions For Use for additional
important information.
Mammotome®, Mammotome elite® are trademarks of Devicor® Medical Products, Inc.
10G | 13G
Introducer Stylet
Stylet introducteur
Einführmandrin
Stiletto introduttore
Estilete Introdutor
Estilete introductor
Geleider Naald
Mandryn prowadzący
인트로듀서 스타일렛
导引探针
イントロデューサースタイレット

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Single-use only.
Device Description
The Mammotome elite® Introducer Stylet should only be used with the Mammotome elite®
Breast Biopsy System. It is composed of a stylet, handle and a tip protector. The Introducer Stylet
is designed to operate safely when used together with the Mammotome elite® Breast Biopsy
System as described in the Instructions for Use below.
Indications
The Mammotome elite® Biopsy System is indicated to obtain tissue samples from the breast or
axillary lymph nodes for diagnostic analysis of breast abnormalities.
• The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic
examination with partial or complete removal of the imaged abnormality.
• The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic
examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from the palpation
or imaged appearance of these abnormalities. Therefore, the extent of removal of the palpated
or imaged evidence of an abnormality does not predict the extent of removal of a histologic
abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it
is essential that the tissue margins be examined for completeness of removal using standard
surgical procedures.
In instances when a patient presents with a palpable abnormality that has been classified as
benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the
Mammotome elite® Biopsy System may also be used to partially remove such palpable lesions.
Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care.
When the sampled abnormality is not histologically benign, it is essential that the tissue margins
be examined for completeness of removal using standard surgical procedures.
Contraindications
• This instrument is for diagnostic use only and is not indicated for therapeutic use.
• This instrument is contraindicated for those patients where increased risk or complications
may be associated with core removal or biopsy based upon the physician’s judgment. Patients
receiving anticoagulant therapy or who may have bleeding disorders may be at increased risk.
Warnings and Precautions
• Minimally invasive procedures should be performed only by persons having adequate
training and familiarity with minimally invasive techniques, complications, and hazards
prior to performance of any minimally invasive procedure.
• The instrument should only be used by physicians trained in percutaneous needle
techniques for tissue collection.
• Special care should be taken to avoid bending or twisting the Introducer Stylet.
• If the Introducer Stylet is bent, do not use. Dispose of the Introducer Stylet in an
appropriate container.
• The Introducer Stylet is not designed for percutaneous skin puncture.
• As with any biopsy instrument, there may be a potential for infection.
• Do not use this instrument in conjunction with Magnetic Resonance Imaging (MRI).
• Use sterile technique in all phases of the use of this product.
• The Introducer Stylet must only be used with Mammotome elite® Biopsy System.
• Products manufactured or distributed by companies not authorized by Devicor®
Medical Products, Inc. may not be compatible with the Mammotome elite® Introducer
Stylet. Use of such products may lead to unanticipated results, EMC issues and
possible injury to the user or patient.

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• Instruments or devices which come into contact with bodily fluids may require
special disposal handling to prevent biological contamination.
• Dispose of all opened disposable instruments whether used or unused.
• If the patient-contacting components of the sterile Introducer Stylet should come
in contact with a non-sterile surface, the Introduer Stylet shall be disposed of in an
appropriate container.
• The Introducer Stylet is packaged and sterilized for single use only. Do not reuse,
reprocess or resterilize. Reuse, reprocessing or resterilization may compromise
the structural integrity of the device and/or lead to device failure that in turn may
result in patient injury, illness or death. Also, reprocessing or resterilization of single
use devices may create a risk of contamination and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of infectious disease(s)
from one patient to another. Contamination of the device may lead to injury, illness,
or death of the patient.
Potential Complications
• Potential complications are those associated with any percutaneous removal/biopsy
technique for tissue collection. Potential complications are limited to the region
surrounding the biopsy site and include hematoma, hemorrhage, infection, pain and
tissue adherence to the introducer stylet while removing it from the breast.
• As per routine biopsy procedures, it may be necessary to cut tissue adhering to the
Introducer Stylet while removing it from the breast
Figure 1. Introducer Stylet nomenclature
Stylet Handle
Tip Protector
Equipment Required
• Ultrasound imaging modality and accessories
• Mammotome elite® Biopsy Holster
• Mammotome elite® Biopsy Probe
• Mammotome elite® Introducer Stylet
• Surgical gloves and drapes
• Local anesthetic
• Scalpel
• Other equipment as necessary
Instructions for Use
IMPORTANT: Inspect all packaging before use. If product packaging is compromised or product
is dropped when removing packaging, dispose of the Mammotome elite® Introducer Stylet as
it is no longer a sterile instrument.
As a reference, refer to the instructions for use for the Mammotome elite® Probe & Holster
1. Load the Probe into the Holster as described in the Mammotome elite® Probe &
Holster IFU. Leave the protective sleeve on the Probe’s trocar shaft.
2. Simultaneously remove the integrated coaxial cannula and the protective sleeve from
the Probe (See Figure 2).
Figure 2

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3. Using sterile technique, remove the Introducer Stylet from the package and discard the
stylet protector. Ensure the introducer stylet remains sterile (See Figure 3).
Figure 3
4. Install the Introducer Stylet into the coaxial cannula (See illustration 4). Ensure the
coaxial cannula is locked onto the Introducer Stylet hub.
Figure 4
5. Prepare the percutaneous site in accordance with standard surgical technique prior to
insertion of the Mammotome elite® introducer.
6. Incise the selected area adequately to accommodate the Mammotome elite®
introducer.
7. Remove the protective sleeve (See illustration 5).
Figure 5
8. Introduce the Mammotome elite® introducer through the incision and position the tip
in the target area with the tip past the lesion. Imaging guidance should be used as
appropriate.
9. Disconnect the Coaxial Cannula and remove the Introducer Stylet, leaving the cannula
in place, by pressing the Coaxial Release Button (See Figure 6). Discard the Introducer
Stylet as appropriate.
Figure 6
10. Insert the Mammotome elite® Probe into the Coaxial Cannula and ensure it is locked
into place.
11. Perform the tissue sampling procedure as described in the Mammotome elite®
Instructions for Use.
CAUTION: Introducer Stylet and Probe are meant for SINGLE-USE ONLY. Dispose of both
immediately after use.

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CAUTION: Do not recap Introducer Stylet tip.
Customer Service Information
Additional information about the Mammotome elite® Biopsy System may be obtained by
calling 1-877-9-A-MAMMO (1-877-926-2666)
(U.S. only; in the EU call800 918 200 or 0 800 500 98 98); sending an e-mail to
[email protected]; or accessing our website at www.mammotome.com
How Supplied
• The Mammotome elite® Introducer Stylet is supplied sterile for single patient use and sold
separately. Discard after use.
Limited Warranty
Devicor® Medical Products, Inc. (“Devicor”) warrants this product as shipped to purchaser
shall be free from defects in material and workmanship under normal use.
Devicor’s obligation under this warranty is limited to the replacement or repair (at Devicor’s
option) of the product or its parts, provided the product has been returned to Devicor
(orDevicor’s Distributor) within ninety days of shipment to the purchaser, and provided
Devicor determines to its satisfaction upon examining the returned product that the product
was defective as originally shipped. This limited warranty does not apply to any product, or
part thereof, that has been: (1) adversely affected due to use with devices manufactured or
distributed by parties not authorized by Devicor; (2) altered in any way other than as approved
by Devicor; (3) damaged, or subjected to improper use, negligence or accident; or (4) used
other than in accordance with the design and use parameters, instructions, and guidelines for
the product, or used other than in accordance with functional, operational or environmental
standards for similar products generally accepted in the industry.
ALL OTHER WARRANTIES WHETHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED
TO THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE,
ARE EXPRESSLY DISCLAIMED TO THE FULLEST EXTENT PERMITTED BY LAW. THIS LIMITED
WARRANTY IS IN LIEU OF ALL OTHER OBLIGATIONS OR LIABILITIES ON THE PART OF DEVICOR
AND IS A PURCHASER’S EXCLUSIVE REMEDY. IN NO EVENT SHALL DEVICOR BE LIABLE FOR
PUNITIVE, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR DAMAGES RESULTING
FROM LOSS OF USE, PROFITS, BUSINESS, OR GOODWILL.
Devicor neither assumes nor authorizes any other person to assume for it any other liability in
connection with the sale or use of any Devicor products. There are no warranties that extend
beyond the terms hereof. Devicor reserves the right to make product changes at any time
without incurring any obligation to make the same or similar changes to products previously
sold or provided by Devicor.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Consult a MAMMOTOME Sales Representative for details regarding replacement options.