DISPOSABLE BIOPSY FORCEPS FB-210U (UDI 04953170031021)Recalls & reported problems
Olympus Medical Systems Corp. · DISPOSABLE BIOPSY FORCEPS · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170031021), received between Mar 3, 2023 and Sep 18, 2025 — classified as 2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Dull, Blunt1
Patient problems
- Gastrointestinal Hemorrhage1
- Hemorrhage/Blood Loss/Bleeding1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A THERAPEUTIC COLONOSCOPY, WHEN DISPOSABLE BIOPSY FORCEPS WERE USED BLEEDING OCCURRED WHICH REQUIRED A CLIP.
Patient problems: Gastrointestinal Hemorrhage
MAUDE report 23083963 ↗InjuryMar 3, 2023Dull, Blunt; Dull, Blunt
A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A DISPOSABLE BIOPSY FORCEPS, THE SURGEON COMPLAINED ABOUT THE JAW BEING NOT SHARP WHILE TAKING A TISSUE SAMPLE. THIS CAUSED A BAD CUTTING BORDER. ADDITIONALLY IT TORE TISSUE AND BLEEDING (STATED TO BE "NOT MUCH") OCCURRED IN THE COLON. ADDITIONAL INFORMATION REGARDING INTERVENTIONS AND OUTCOME WAS REQUESTED MULTIPLE TIMES WITHOUT RESPONSE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 16482129 ↗
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.