Tissue Retrieval System TRS070Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00612376000050), received between Jul 16, 2019 and Jul 16, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• InjuryJul 16, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE TRS070, SPECIMEN BAG, WAS USED DURING A CHOLECYSTECTOMY ON (B)(6) 2019 AND WAS FOUND TO HAVE A HOLE IN AFTER THE SPECIMEN WAS RETRIEVED. THE SURGICAL TEAM IS UNSURE IF THE FRAGMENT REMAINS IN THE PATIENT OR IF IT WAS REMOVED WHEN THE SUCTION AND IRRIGATION WAS USED. THIS REPORT IS BEING RAISED AS A PATIENT INJURY DUE TO THE UNKNOWN LOCATION OF THE SPECIMEN BAG FRAGMENT AND THE POSSIBILITY THAT IT REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8794443 ↗