DISPOSABLE BIOPSY FORCEPS FB-230U (REF N5355530)Recalls & reported problems
Olympus Medical Systems Corp. · Class 1
All models of DISPOSABLE BIOPSY FORCEPS (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170354137), received between Dec 25, 2018 and Jul 1, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Dull, Blunt” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Dull, Blunt1
Patient problems
- Bruise/Contusion1
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
- Tissue Damage1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT DURING A PROCEDURE THE SUBJECT DEVICE WAS NOT SHARP WHILE TAKING SAMPLE TISSUE WHICH CAUSED A BAD CUTTING BORDER, TEARING TISSUE AND BLEEDING. A FEW CLIPS WERE USED TO STOP THE BLEEDING AND THE CASE WAS COMPLETE. THERE WAS NO REPORTED HARM TO THE PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19650425 ↗InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN OLYMPUS SALES REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER, THAT DURING AN UNSPECIFIED PROCEDURE WITH BIOPSY, A SUBMUCOSAL HEMATOMA OCCURRED AND WAS RESOLVED WITH A HEMOSTATIC CLIP. THE REPORTER STATES THAT THE PATIENT SUFFERED NO OTHER INJURIES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THERE WERE NO FURTHER REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: Bruise/Contusion; Hematoma
MAUDE report 16400616 ↗InjuryDec 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A COLONIC BIOPSY, THE SUBJECT DEVICE WAS USED. IT WAS REPORTED THAT THE DEVICE DAMAGED TISSUE AND THE PATIENT HAD A BLEEDING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 8194740 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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