Tissue Retrieval System TRS080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00612376000036), received between May 20, 2019 and May 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED VIA (B)(6) INCIDENT # - (B)(4). IT WAS REPORTED THAT THE TRS080, ANCHOR BAG WAS USED IN A CHOLECYSTECTOMY ON (B)(6) 2019. IT WAS INTRODUCED INTO THE ABDOMEN TO RETRIEVE THE GALL BLADDER (THIS IS NORMAL PRACTICE) THE GALL BLADDER WAS PLACED IN THE RETRIEVAL BAG WITH A 2X2 SWAB AGAIN (NORMAL PRACTICE). AS THE SURGEON WENT TO PULL ON THE STRING OF THE RETRIEVAL BAG TO BRING IT OUT VIA THE PORT HOLE THE UPPER PART OF THE BAG COMPLETELY CAME AWAY FROM THE BOTTOM PART. ADDITIONAL INFORMATION WAS REQUESTED BUT NONE WAS RECEIVED. THERE WAS NO REPORTED PATIENT INJURY OR IMPACT. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8624013 ↗