How Supplied

Contents are sterile for single patient use only.

Do not use if the package is opened or damaged.

Do not re-sterilise.

Contraindications

This device is not intended for use when endoscopic techniques are contraindicated.

Cautions/Warnings

1. This device is designed for single use only, and is not to be reused or re-sterilised. Do not Use if package is opened or damaged.

2. Endoscopic procedures should be performed only by physicians with adequate training and knowledge of these procedures. In addition, medical literature should be consulted regarding techniques, hazards, contraindications, and complications prior to the performance of these procedures.

3. Before endoscopic instruments and accessories from different manufacturers are utilised together in a procedure, verify compatibility and ensure that electrical isolation of ground is not compromised.

4. A thorough understanding of techniques and principles involved in electrosurgical procedures is necessary to avoid burn or shock hazard to patient and or operator.

Indications for Use

To be used for removal of tissue specimens during a suitable Laparoscopic procedure.

Instructions for Use

1. Insert the EndoPouch through a 10, 11 or 12mm cannula.

2. To remove the pouch from the introducer, push the inner introducer forwards. The pouch will release and deploy automatically.

3. Use an appropriate laparoscopic instrument to place the specimen into the retrieval bag.

4. To close the pouch, grasp the green mark on the memory wire with a grasper and pull the distal end of the memory wire with another grasper.

5. To remove the pouch, use a grasper to pull the top of the pouch into the distal end of a cannula. Withdraw the cannula, grasper and pouch until the pouch can be visualised outside the incision. Remove the pouch from the incision by hand. If the retrieval bag with specimen cannot be removed, enlargement of the access site is recommended for easier removal.