DISPOSABLE BIOPSY FORCEPS FB-211K (REF N1080820)Recalls & reported problems
Olympus Medical Systems Corp. · DISPOSABLE BIOPSY FORCEPS · Class 1
All models of DISPOSABLE BIOPSY FORCEPS (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 04953170157974), received between Dec 30, 2019 and Feb 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Difficult to Open or Close
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BIOPSY FORCEPS EXHIBITED FOREIGN MATTER WAS ADHERING ON THE FORCEPS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24475031 ↗MalfunctionDec 30, 2019Break; Break
THE SERVICE CENTER RECEIVED A REPORT OF A BIOPSY FORCEPS (FB-211K) THAT HAD A JAW BREAK OFF DURING A PROCEDURE, AND FELL INTO THE PATIENT. THE FB-211K WAS INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE OBSERVED. THE PHYSICIAN WAS IN THE MIDDLE OF AN ENDOSCOPY WITH BIOPSY PROCEDURE, WHEN THE JAW OF THE FORCEPS BROKE OFF AND FELL INTO THE ESOPHAGUS OF THE PATIENT. THE ITEM WAS RETRIEVED BY THE PHYSICIAN USING A STERIS ROTH NET. IT WAS REPORTED THIS EVENT DELAYED THE PROCEDURE APPROXIMATELY FOR FIVE MINUTES AND THERE WAS NO BLOOD LOSS TO THE PATIENT. THE REPORT INDICATED NO OTHER INSTRUMENTS WERE REPLACED DURING THE PROCEDURE, AND THAT A SECOND SET OF FORCEPS WAS USED TO CONTINUE TAKING ESOPHAGEAL BIOPSIES. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9532913 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page