DISPOSABLE BIOPSY FORCEPS FB-220U (UDI 04953170031076)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170031076), received between Oct 4, 2018 and Jun 26, 2019 — classified as 4 injuries, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2019Mechanical Problem; Mechanical Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THAT THE PATIENT'S SAMPLE FELL FROM THE FORCEPS INTO THE SCOPE¿S BIOPSY VALVE. THE USER FACILITY¿S STAFF MEMBER REMOVED THE BIOPSY VALVE TO RETAIN THE SAMPLE AND WAS SPLASHED IN THE EYE WITH BIOBURDEN. THE STAFF MEMBER WAS WEARING PROTECTIVE EYEWEAR WHEN THE INCIDENT OCCURRED. BOTH THE PATIENT AND THE FACILITY¿S STAFF MEMBER WERE BLOOD PANEL TESTED. THE STAFF MEMBER WAS PLACED ON PROPHYLACTICS AS A PRECAUTIONARY MEASURE, WHILE TEST RESULTS WERE PENDING. THE PATIENT AND STAFF MEMBER¿S BLOOD TEST WERE NEGATIVE FOR ANY CROSS CONTAMINATION. IN ADDITION, THE USER FACILITY REPORTED THAT THERE HAS BEEN A COMMON OBSERVATION WHEN USING THIS DEVICE THAT THE PHYSICIAN HAS BEEN UNABLE TO RETAIN PATIENT SAMPLES WHILE TRANSFERRING TISSUE SAMPLES FROM THE SCOPE TO A COLLECTION RECEPTACLE. THE USER FACILITY BELIEVES THAT THERE MAY BE AN ISSUE WITH THE GRASP OF THE DEVICE.

  Patient problems: No Code Available

  MAUDE report 8735644 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A COLONOSCOPY PROCEDURE, THE FORCEP WAS NOT GRABBING THE TISSUE PROPERLY CAUSING THE PATIENT¿S MUCOSA TO TEAR WITH MODERATE BLEEDING. THE BLEEDING WAS TREATED BY APPLYING CLIPS TO THE AFFECTED AREA. THIS RESULTED IN A SHORT DELAY. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. ADDITIONALLY, THE USER FACILITY REPORTED THAT AT NO TIME WAS FORCE APPLIED TO ASSIST DEVICE OPERATION. THERE WERE NO ISSUES INSERTING OR WITHDRAWING DEVICE FROM THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE AND THERE WERE NO ABNORMALITIES.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 8352062 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A COLONOSCOPY PROCEDURE, THE FORCEP WAS NOT GRABBING THE TISSUE PROPERLY CAUSING THE PATIENT¿S MUCOSA TO TEAR WITH MODERATE BLEEDING. THE BLEEDING WAS TREATED BY APPLYING CLIPS TO THE AFFECTED AREA. THIS RESULTED IN A SHORT DELAY. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. ADDITIONALLY, THE USER FACILITY REPORTED THAT AT NO TIME WAS FORCE APPLIED TO ASSIST DEVICE OPERATION. THERE WERE NO ISSUES INSERTING OR WITHDRAWING DEVICE FROM THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE AND THERE WERE NO ABNORMALITIES.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 8351852 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A COLONOSCOPY PROCEDURE, THE FORCEP WAS NOT GRABBING THE TISSUE PROPERLY CAUSING THE PATIENT¿S MUCOSA TO TEAR WITH MODERATE BLEEDING. THE BLEEDING WAS TREATED BY APPLYING CLIPS TO THE AFFECTED AREA. THIS RESULTED IN A SHORT DELAY. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. ADDITIONALLY, THE USER FACILITY REPORTED THAT AT NO TIME WAS FORCE APPLIED TO ASSIST DEVICE OPERATION. THERE WERE NO ISSUES INSERTING OR WITHDRAWING DEVICE FROM THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE AND THERE WERE NO ABNORMALITIES.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 8351520 ↗
• MalfunctionOct 4, 2018Break; Break

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE NEEDLE FROM THE FORCEPS BROKE OFF AND FELL INTO THE PATIENT. THE DEVICE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Alteration In Body Temperature

  MAUDE report 7934774 ↗