Device Dossier

Bag, tissue extraction

Device Dossier for Bag, tissue extraction (Bag, tissue extraction, Class IIa, sponsor Fortress Surgical). ARTG record, intended purpose, GMDN category —…

Intended purpose

The Auto Retrieval Pouch is a single-use sterile medical device intended for the collection and removal of tissue, organs and calculi from the body cavity during general and laparoscopic surgical procedures. The device is designed to be introduced through a trocar or cannula into the body cavity, where the pouch is deployed to capture and contain the specimen, which is then withdrawn through the trocar port. The device consists of an outer tube, inner tube, handle of outer tube, handle of inner tube, deployment assembly, drawstring thread and pouch. It is available in multiple models (MEBC, MEBD, MEBS, MEBW and MEBM) with pouch volumes ranging from 50 mL to 1200 mL. The device is intended for single use only and is supplied sterile (ethylene oxide sterilisation). It is intended for use by trained physicians with adequate knowledge and experience in endoscopic and laparoscopic surgical procedures, in a licensed hospital or surgical facility under appropriate medical supervision. The device is not intended for use where endoscopic techniques are contraindicated.

TGA Public Summary