DISPOSABLE HOT BIOPSY FORCEPS FD-230U (UDI 04953170158766)Recalls & reported problems
Olympus Medical Systems Corp. · DISPOSABLE HOT BIOPSY FORCEPS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170158766), received between Sep 27, 2018 and Sep 27, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Activation 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.
Most reported problems
Device problems
- Activation Problem1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2018Activation Problem; Activation Problem
OLYMPUS WAS INFORMED THAT DURING AN UNKNOWN PROCEDURE, THE PHYSICIAN INITIALLY THOUGHT THE DEVICE WAS NOT ACTIVATING ON THE INTENDED POLYP TISSUE. THE CLINICIAN LATER NOTICED THAT HE HAD PERFORATED PAST THE MUCOSA AND HE WAS ABLE TO SEE THE INTESTINES. THE PATIENT HAD TO BE SENT OUT FOR SURGICAL INTERVENTION. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN.
Patient problems: Perforation
MAUDE report 7915548 ↗
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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