Single Use Biopsy Forceps FB-225U (REF N5998530)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170408274), received between Aug 14, 2019 and Jul 2, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED BY THE CUSTOMER FOR THIS EVENT, THERE WAS SHIPMENT DAMAGE TO OUTSIDE OF THE PACKAGING AND ALSO DAMAGE TO THE BOXES CONTAINING THE DEVICES. TOTAL 38 PIECES WERE IN THE SHIPMENT PACKAGE AND ALL WERE RETURNED FOR INSPECTION. UPON VISUAL INSPECTION OF THE RETURNED DEVICES, FIVE OUT OF THE 38 WERE TORN OR DAMAGED WITH HOLES, THUS BREACHING STERILITY. THIS MEDWATCH IS BEING SUBMITTED FOR THE FIRST DEVICE DAMAGED WITH HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108825 ↗
• MalfunctionJul 2, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED BY THE CUSTOMER FOR THIS EVENT, THERE WAS SHIPMENT DAMAGE TO OUTSIDE OF THE PACKAGING AND ALSO DAMAGE TO THE BOXES CONTAINING THE DEVICES. TOTAL 38 PIECES WERE IN THE SHIPMENT PACKAGE AND ALL WERE RETURNED FOR INSPECTION. UPON VISUAL INSPECTION OF THE RETURNED DEVICES, FIVE OUT OF THE 38 WERE TORN OR DAMAGED WITH HOLES, THUS BREACHING STERILITY. THIS MEDWATCH IS BEING SUBMITTED FOR THE FOURTH DEVICE DAMAGED WITH HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108778 ↗
• MalfunctionJul 2, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED BY THE CUSTOMER FOR THIS EVENT, THERE WAS SHIPMENT DAMAGE TO OUTSIDE OF THE PACKAGING AND ALSO DAMAGE TO THE BOXES CONTAINING THE DEVICES. TOTAL 38 PIECES WERE IN THE SHIPMENT PACKAGE AND ALL WERE RETURNED FOR INSPECTION. UPON VISUAL INSPECTION OF THE RETURNED DEVICES, FIVE OUT OF THE 38 WERE TORN OR DAMAGED WITH HOLES, THUS BREACHING STERILITY. THIS MEDWATCH IS BEING SUBMITTED FOR THE THIRD DEVICE DAMAGED WITH HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108758 ↗
• MalfunctionJul 2, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED BY THE CUSTOMER FOR THIS EVENT, THERE WAS SHIPMENT DAMAGE TO OUTSIDE OF THE PACKAGING AND ALSO DAMAGE TO THE BOXES CONTAINING THE DEVICES. TOTAL 38 PIECES WERE IN THE SHIPMENT PACKAGE AND ALL WERE RETURNED FOR INSPECTION. UPON VISUAL INSPECTION OF THE RETURNED DEVICES, FIVE OUT OF THE 38 WERE TORN OR DAMAGED WITH HOLES, THUS BREACHING STERILITY. THIS MEDWATCH IS BEING SUBMITTED FOR THE SECOND DEVICE DAMAGED WITH HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108672 ↗
• MalfunctionJul 2, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED BY THE CUSTOMER FOR THIS EVENT, THERE WAS SHIPMENT DAMAGE TO OUTSIDE OF THE PACKAGING AND ALSO DAMAGE TO THE BOXES CONTAINING THE DEVICES. TOTAL 38 PIECES WERE IN THE SHIPMENT PACKAGE AND ALL WERE RETURNED FOR INSPECTION. UPON VISUAL INSPECTION OF THE RETURNED DEVICES, FIVE OUT OF THE 38 WERE TORN OR DAMAGED WITH HOLES, THUS BREACHING STERILITY. THIS MEDWATCH IS BEING SUBMITTED FOR THE FIFTH DEVICE DAMAGED WITH HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108664 ↗
• MalfunctionNov 18, 2020Device Reprocessing Problem; Material Twisted/Bent; Device Reprocessing Problem; Material Twisted/Bent

  ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER: THERE WAS NO POSITIVE LEAK/CULTURE RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10859941 ↗
• MalfunctionNov 18, 2020Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER: THERE WAS NO POSITIVE LEAK/CULTURE RELATED TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10859936 ↗
• MalfunctionJul 31, 2020Material Twisted/Bent

  PHYSICIAN WAS INSERTING BIOPSY FORCEPS INTO THE SCOPE WHEN HE HEARD A "POP", HE STATES THAT NORMALLY HE HEARS A SLIGHT "POP" THE TIME A DEVICE IS INSERTED THROUGH THE BIOPSY PORT COVER SO HE THOUGHT THAT WAS WHAT THIS WAS. WHEN THE SCOPE WAS FULLY INSERTED AND APPEARED OUT THE END OF THE SCOPE, HE NOTED THAT THE DISTAL END OF THE FORCEPS WAS BENT. PHYSICIAN REMOVED THE FORCEPS AND OBTAINED ANOTHER ONE, BENT ONE WAS SEQUESTERED FOR RISK. FDA SAFETY REPORT ID (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10355895 ↗
• MalfunctionJul 24, 2020Material Twisted/Bent

  FORCEPS DISTAL END BENT AS IT WAS BEING ADVANCED DOWN SCOPE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10325938 ↗
• MalfunctionAug 14, 2019Use of Device Problem; Use of Device Problem

  THE SERVICE CENTER WAS INFORMED THAT WHILE USING THE DEVICE, THE TEETH ON THE JAWS WERE NOT SHARP AND WERE TEARING THE MUCOSA INSTEAD OF CUTTING IT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Tissue Damage

  MAUDE report 8894826 ↗