DISPOSABLE BIOPSY FORCEPS FB-244U (REF N5356430)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170354229), received between Oct 23, 2018 and Nov 14, 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. 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
- Adverse Event Without Identified Device or Use Problem1
- Dull, Blunt1
Patient problems
- Blood Loss1
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2025Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT DURING A COLONOSCOPY AND POLYPECTOMY, DUE TO THE INSUFFICIENT SHARPNESS OF THE BIOPSY CUP, THE MUCOSA WAS TORN, RESULTING IN BLEEDING THAT REQUIRED HEMOSTASIS WITH A CLIP. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23555189 ↗InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS WAS INFORMED THAT THE USER FACILITY¿S PHYSICIANS REPORTED FEELING A TEARING SENSATION WHEN USING THE SINGLE USE BIOPSY FORCEPS, AS A RESULT 5 TO 6 PATIENTS EXPERIENCED EXCESSIVE BLEEDING AND HEMATOMAS. CLIPS WERE USED TO TREAT THE BLEEDING AND CLOSE THE AFFECTED SITE. IT IS UNKNOWN IF THE INTENDED PROCEDURES WERE COMPLETED. ADDITIONALLY, IT WAS REPORTED THAT THE CLINICIANS WERE NEW TO THE USE OF THIS FORCEP, ALTHOUGH A PREVIOUS TRIAL WAS COMPLETED. THIS IS REPORT 3 OF 6.
Patient problems: Blood Loss; Hematoma
MAUDE report 7997573 ↗
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