Tissue Retrieval System TRS-ROBO-8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00612376000111), received between Aug 6, 2018 and Aug 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionAug 6, 2018Break; Break

  THE CUSTOMER REPORTED THE METAL RING CAME THROUGH THE BAG (TRS-ROBO-8) WHILE IN THE PATIENT. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT, NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED AS EXPECTED. PHOTOGRAPHS WERE PROVIDED AND THE DEVICE WAS RETURNED. BASED ON THE INFORMATION RECEIVED AND THE DECISION TREE RESULTS, THIS DOES MEET THE DEFINITION OF A REPORTABLE EVENT. THIS REPORTING IS BEING RAISED AS A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753362 ↗