Single Use Biopsy Forceps FB-225U (UDI 04953170398858)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170398858), received between Jul 24, 2018 and Oct 4, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SERVICE CENTER WAS INFORMED THAT THE CUSTOMER REPORTED THAT EXCESSIVE BLEEDING MAYBE CAUSED DUE TO THE DEEP BITE OF THESE FORCEPS. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9157383 ↗
• MalfunctionJan 22, 2019Break; Break

  OLYMPUS WAS INFORMED THAT IN THE MIDDLE OF AN EGD PROCEDURE, WHILE THE DEVICE WAS SAMPLING GASTRIC ANTRAL TISSUE, A SINGLE PIECE OF THE JAW FELL OFF THE DEVICE AND INTO THE PATIENT. THE PIECE WAS RETRIEVED USING ANOTHER FORCEPS DEVICE THAT WAS ALSO USED TO COMPLETE THE PROCEDURE. THERE WAS NO TRAUMA TO THE PATIENT AND MINIMAL BLEEDING FROM THE BIOPSY SITES. THE DEVICE HAD BEEN INSPECTED BEFORE USE WITH NO ANOMALIES FOUND. IT WAS REPORTED THAT PRIOR TO USE, THE PINK PROTECTIVE TIP OF THE DEVICE WAS DIFFICULT TO REMOVE.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8269050 ↗
• InjuryJul 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY INFORMED OLYMPUS THAT PATIENTS ARE EXPERIENCING EXCESSIVE BLEEDING AFTER UNDERGOING PROCEDURES WITH THE SINGLE USE BIOPSY FORCEPS. IT IS NOT KNOWN HOW THE BLEEDING WAS RESOLVED OR IF THE INTENDED PROCEDURES WERE COMPLETED. ADDITIONALLY, THE USER FACILITY REPORTED THAT ALTHOUGH THERE WAS NO ISSUES NOTED WITH THE DEVICE DURING USE IT CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THIS IS REPORT 2 OF 2.

  Patient problems: Blood Loss

  MAUDE report 7716671 ↗