DISPOSABLE HOT BIOPSY FORCEPS FD-230U (REF N5356630)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170354243), received between Apr 1, 2021 and Jul 21, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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
- Manufacturing, Packaging or Shipping Problem1
- Use of Device Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THE SUBJECT DEVICE COVERED IN SOME SORT OF FRAGRANT DETERGENT. IT LOOKS LIKE THE ORIGINAL BOX WAS DAMAGED AND IT WAS REPACKED IN ANOTHER BOX . THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561568 ↗InjuryApr 1, 2021Use of Device Problem; Use of Device Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED ABOUT FOLLOWING EVENT BY THE CUSTOMER. THE PATIENT CAME TO THE HOSPITAL WITH BLEEDING VERY HEAVILY. THE STAFF TRIED TO STOP THE BLEEDING WITH THE SUBJECT DEVICE, BUT IT DIDN'T SUCCEED. ACCORDING TO THE NURSE, THE SUBJECT DEVICE DID NOT WORK AND THE BLEEDING WAS NOT STOPPED. THE PATIENT HAD TO UNDERGO SURGERY. THE SUBJECT DEVICE WAS USED WITH THE MARTIN KLS HIGH FREQUENCY DEVICE. AT A LATER DATE, THE DOCTOR STATED THAT THE PATIENT'S CONDITION WAS VERY ACUTE AND HAD TO BE OPERATED ON ANYWAY, BUT THE SUBJECT DEVICE DID NOT PRESENT ANY ABNORMALITIES.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 11600932 ↗
Other FORCEPS, BIOPSY, ELECTRIC devices
- HALOGEN LIGHT SOURCE OLYMPUS CLK-4Olympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC65 reports
- Single Use Electrosurgical Hemostatic Forceps FD-410LROlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC46 reports
- Radial Jaw 4 M00515030Boston Scientific Corporation · FORCEPS, BIOPSY, ELECTRIC29 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5AOlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC24 reports
- Single Use Electrosurgical Hemostatic Forceps FD-412LROlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC17 reports
- Single Use Electrosurgical Hemostatic Forceps FD-411UROlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC15 reports
- SUCTION VALVE MAJ-207Olympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC13 reports
- Captura G31583Cook Incorporated · FORCEPS, BIOPSY, ELECTRIC13 reports
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.
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