BIOPSY FORCEPS FB-19SX-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170029646), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 18, 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.

• MalfunctionDec 6, 2022Device Reprocessing Problem; Contamination /Decontamination Problem; Device Reprocessing Problem; Contamination /Decontamination Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT THE BIOPSY FORCEPS CUP DID NOT OPEN DURING TESTING. IT WAS REPORTED THAT THE EVENT OCCURRED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, FOREIGN MATERIALS WERE FOUND ON THE ARMS OF THE FORCEPS CUPS (THE LINKAGE MECHANISM AT THE DISTAL END) DUE TO INCORRECT REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE NORMAL REPROCESSING PROCESS INVOLVES MANUAL CLEANING AFTER USE, FOLLOWED BY BRUSHING AND CLEANING WITH A DROPPER, THEN AUTOCLAVE STERILIZED. BUT LUBRICANT USE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924716 ↗