DISPOSABLE BIOPSY FORCEPS FB-231K (UDI 04953170158049)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170158049), received between Jun 24, 2019 and Aug 27, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing 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 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.

• MalfunctionAug 27, 2025Residue After Decontamination; Residue After Decontamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISPOSABLE BIOPSY FORCEPS EXHIBITED FOREIGN MATERIAL (FRAGMENTS) THAT FELL INTO THE STOMACH WHEN OPERATING THE BIOPSY FORCEPS IN THE STOMACH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904549 ↗
• MalfunctionJun 16, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISPOSABLE BIOPSY FORCEPS EXHIBITED A FOREIGN SUBSTANCE ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214849 ↗
• MalfunctionMay 20, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISPOSABLE BIOPSY FORCEPS EXHIBITED FOREIGN MATERIAL ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054211 ↗
• MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THE CABLE OF THE DISPOSABLE BIOPSY FORCEPS HEAD CAME LOOSE AND WAS REMOVED. THE ISSUE OCCURRED DURING A DIAGNOSTIC UPPER GASTROINTESTINAL ENDOSCOPY. THE PROCEDURE WAS NOT COMPLETED AS IT HAD BEEN CANCELLED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20337059 ↗
• InjuryJun 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENTS WERE REPORTED IN THE 97TH CONGRESS OF JGES (JAPAN GASTROENTEROLOGICAL ENDOSCOPY SOCIETY). TITLE: O02-5 THE STUDY OF THE OCCURRENCE FREQUENCY OF ACCIDENTAL BLEEDING AFTER THE BIOPSY DURING THE UPPER GASTROINTESTINAL ENDOSCOPY UNDER THE ANTITHROMBOTIC TREATMENT. <SUMMARY>: THE FACILITY PERFORMED UPPER GASTROINTESTINAL ENDOSCOPY AND GASTRIC BIOPSY WITH COMPACT FORCEPS TO PATIENTS UNDER NON-DISCONTINUATION OF DRUG AND REPORTED THE OCCURRENCE FREQUENCY OF ACCIDENTAL BLEEDING AFTER THE BIOPSY. FROM MARCH 2012 TO MARCH 2018, THE FACILITY PERFORMED THE UPPER GASTROINTESTINAL ENDOSCOPY OF 34872 CASES. THERE WERE 20370 MALES AND 14502 FEMALES IN THE STUDY. THE MEAN AGE OF THE PATIENTS WAS 69.5 YEARS-OLD. THE FACILITY PERFORMED THE BIOPSY WITH FB-231K ON 9072 CASES IN THE 34872 CASES. THE BREAKDOWN OF THE 9072 CASES WAS AS FOLLOWS; THE NUMBER OF THE GROUP FOR NON-TAKING ANTITHROMBOTIC DRUG WAS 7800 CASES, NON-DISCONTINUATION OF ANTIPLATELET DRUG WAS 1059 CASES, NON-DISCONTINUATION OF ANTICOAGULANT DRUG WAS 171 CASES (WARFARIN: 100 CASES, DIRECT ORAL ANTICOAGULANTS (DOAC): 71 CASES) AND TAKING BOTH ANTIPLATELET DRUG AND ANTICOAGULANT WAS 42 CASES. THE FACILITY CONFIRMED WH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8726637 ↗