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3 Devices with moving parts should be evaluated for proper function<br />

prior to use. If damage is suspected, contact your local representative<br />

for replacement by the manufacturer.<br />

4 Laparoscopic procedures should be performed only by physicians<br />

possessing adequate training and familiarity with laparoscopic<br />

techniques and instruments.<br />

5 When using <strong>MiniLap</strong> Graspers, clinical judgment must be made<br />

regarding the application of the instruments. In all cases, sound<br />

surgical practice is to be followed by the user.<br />

6 When used in laparoscopy, <strong>MiniLap</strong> Graspers should only be inserted<br />

under direct laparoscopic visualization.<br />

7 <strong>MiniLap</strong> Graspers should be handled carefully to avoid inadvertent<br />

damage to the instrument tip.<br />

8 Do not use <strong>MiniLap</strong> Graspers to crush or crimp other surgical<br />

instruments.<br />

Potential Adverse Effects<br />

•<br />

•<br />

•<br />

2<br />

Perforation or internal bleeding<br />

Infection, which can lead to failure of the procedure<br />

Neurovascular injuries due to surgical trauma<br />

Sterilization<br />

•<br />

•<br />

•<br />

<strong>MiniLap</strong> Graspers are provided sterile (gamma radiation).<br />

They are intended for single use only and should be discarded after use.<br />

Do not resterilize.<br />

No other sterilization technique has been validated to ensure the<br />

sterility or functional integrity of the device.<br />

Storage<br />

•<br />

•<br />

•<br />

Store at room temperature.<br />

Avoid prolonged exposure to elevated temperatures.<br />

Do not expose to temperatures above 120°F (49°C).<br />

Instructions for Use<br />

Insertion<br />

<strong>MiniLap</strong> graspers are designed with a built-in insertion needle that allows<br />

for direct introduction into the body without the need for an incision.<br />

1 Press the black locking mechanism on the proximal end of the grasper.<br />

2 Retract the thumb handle to expose the needle tip at the distal end<br />

of the grasper. (The red active needle marker will appear when the<br />

needle is exposed.)<br />

3<br />

Using a #11 blade, create a small puncture at the point of insertion.

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