REFLEX 16052Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405034957), received between Oct 16, 2017 and Oct 16, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of 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.

• MalfunctionOct 16, 2017Detachment Of Device Component; Detachment Of Device Component

  THE USER FACILITY REPORTED THAT DURING A LAPAROSCOPIC BILATERAL TUBAL LIGATION A REFLEX 5MM TROCAR WAS USED AND UPON REMOVAL FROM THE ABDOMEN ONE OF THE PLASTIC SHIELDS ON THE TROCAR SPIKE WAS MISSING. A THOROUGH SEARCH USING A LAPAROSCOPE WITHIN THE ABDOMEN, PELVIS AND TROCAR TRACT DID NOT LOCATE THE SPIKE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE TROCAR AND A 10-MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS DISCHARGED HOME THE SAME DAY IN STABLE CONDITION. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6953820 ↗