BIOPSY FORCEPS FB-46Q-1Recalls & reported problems
Olympus Medical Systems Corp. · FB-46Q-1 STATIC JAW BILIARY BIOP W/RAT T · Class 1
All models of BIOPSY FORCEPS (18)
Data updated Oct 16, 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 04953170030741), received between Jun 10, 2022 and Jun 10, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pancreatitis1
- Unspecified Hepatic or Biliary Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF BILE DUCT BIOPSY USING THE NEW DEVICE DELIVERY SYSTEM ENDOSHEATHER". DIAGNOSIS INCLUDING BENIGN / MALIGNANT DIFFERENTIATION OF BILIARY TRACT STENOSIS CASES IS OFTEN MADE. IT IS DIFFICULT TO COLLECT BILE DUCT TISSUE UNDER ERC. BILE DUCT BIOPSY IS SAID TO BE MORE DIAGNOSTIC THAN SCRAPING CYTOLOGY, AND IF ACCURATE SNIPER BIOPSY IS POSSIBLE, IT IS EXPECTED THAT THE DIAGNOSTIC ABILITY OF BILE DUCT LESIONS AND THE ACCURACY OF PREOPERATIVE MAPPING BIOPSY OF MALIGNANT BILIARY STRICTURES WILL BE IMPROVED. .. WE HAVE DEVELOPED A DEVICE DELIVERY SYSTEM, ENDO SHEATHER (ES), FOR THE PURPOSE OF BILE DUCT BIOPSY. THIS DEVICE CONSISTS OF AN INNER CATHETER COAXIAL WITH THE GUIDE WIRE (GW) AND A TAPERED TIP WITH A SMALL DIAMETER DIFFERENCE, AND AN OUTER SHEATH INTO WHICH DEVICES UP TO 5.7 FR CAN BE INSERTED. INSIDE THE OUTER SHEATH IS A BIOPSY FORCEPS FOR THE LARGE INTESTINE. IT CAN BE INSERTED. BY USING ES, QUICK AND ACCURATE SNIPER BIOPSY OF THE TARGET SITE OF BIOPSY IS EXPECTED. [TYPE OF ADVERSE EVENTS / NUMBER OF PATIENTS] PANCREATITIS 9: MILD 6 MODERATE 1 SEVERE 2, CHOLANGITIS 1.
Patient problems: Pancreatitis; Unspecified Hepatic or Biliary Problem
MAUDE report 14653154 ↗
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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