DISPOSABLE BIOPSY FORCEPS FB-211K (REF N5431430)Recalls & reported problems
Olympus Medical Systems Corp. · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170389481), received between May 31, 2023 and Jun 15, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE DISPOSABLE BIOPSY FORCEPS WAS BROKEN AT THE BEGINNING OF THE DIAGNOSTIC BRONCHIAL BIOPSY PROCEDURE, WHEN REMOVING THE BIOPSY FORCEPS OUT OF THE WORKING CHANNEL AND OPENING THE CUPS, PRIOR TO TAKING BIOPSY SAMPLES. THE PROCEDURE WAS COMPLETED WITH NO DELAY USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17140462 ↗MalfunctionMay 31, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE DISPOSABLE BIOPSY FORCEPS WIRE BROKE ASSOCIATED WITH THE OPENING AND CLOSING MECHANISM DURING BIOPSY. THE ISSUE WAS FOUND DURING PROCEDURE, AND THE TYPE OF PROCEDURE WAS DIAGNOSTIC - BIOPSY. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17032054 ↗
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.