DISPOSABLE BIOPSY FORCEPS FB-214URecalls & reported problems
Olympus Medical Systems Corp. · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170354199), received between Nov 21, 2022 and Nov 21, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2022Use of Device Problem; Use of Device Problem
A NURSE AT THE USER FACILITY REPORTED THAT THE DISPOSABLE BIOPSY FORCEPS WERE ACCIDENTALLY PUT INTO THE INSTRUMENT CHANNEL PORT IN THE PATIENT¿S BODY INSTEAD OF THE INTENDED ENDO JAW BIOPSY FORCEPS, DURING A COLON EXAMINATION. THE USER NOTICED SOMETHING STRANGE AND THEN TOOK THE DEVICE OUT AND DISCOVERED IT WAS THE WRONG PRODUCT. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH THE CORRECT PRODUCT, WITH NO IMPACT TO THE PATIENT. IT WAS NOTED THAT THE SIZE, SHAPE, AND COLOR OF THE CONTENTS ARE VERY SIMILAR, AND IT WAS DIFFICULT TO DISTINGUISH BETWEEN THE DEVICES AT A GLANCE. THE CUSTOMER REQUESTED CHANGING THE COLOR OF THE HANDLE, OR PACKAGING TO PREVENT ACCIDENTAL OPENING OF THE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15834586 ↗
Other FORCEPS, BIOPSY, NON-ELECTRIC devices
- Radial Jaw 4 M00513410Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall24 reports
- Radial Jaw 4 M00513330Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall19 reports
- Radial Jaw 4 M00513400Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall16 reports
- NA 8736685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall15 reports
- NA 828051Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall6 reports
- Radial Jaw 4 M00513320Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall3 reports
- Radial Jaw 4 M00513360Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall2 reports
- NA 8735685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.