REFLEX 16050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405034919), received between Sep 6, 2017 and Sep 6, 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.

• MalfunctionSep 6, 2017Detachment Of Device Component; Detachment Of Device Component

  THE USER FACILITY REPORTED A TROCAR WAS USED FOR A DIAGNOSTIC LAPAROSCOPY. AT THE BEGINNING OF THE PROCEDURE, WHILE THE SURGEON WAS TRYING TO INTRODUCE THE TROCAR INTO THE CAVITY, THE SHIELD AT THE DISTAL END OF THE TROCAR BROKE OFF. THE BROKEN SHIELD WAS UNABLE TO BE LOCATED. THE PROCEDURE WAS COMPLETED WITH A NEW TROCAR AND NO REPORTED SURGICAL DELAYS. THE PATIENT WAS DISCHARGED THE SAME DAY IN STABLE CONDITIONS AFTER ROUTINE POST-OPERATIVE CARE. POST DISCHARGE, THE PATIENT PHONED THE SURGEON'S OFFICE DUE TO BLEEDING AT THE UMBILICUS. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT WHERE SHE HAD A CT SCAN OF THE ABDOMEN WHICH WAS NEGATIVE. THE PATIENT WAS THEN DISCHARGED HOME IN STABLE CONDITION. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6846595 ↗