BIOPSY FORCEPS FB-21K-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170029776), received between Nov 4, 2021 and Aug 9, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (4 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2023Device Reprocessing Problem; Contamination; Device Reprocessing Problem; Contamination

  THE CUSTOMER REPORTED TO OLYMPUS, THE BIOPSY FORCEPS CUP COULD NOT OPEN OR CLOSE. THE EVENT OCCURRED DURING PREPARATION FOR USE. THE INTENDED DIAGNOSTIC PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. DURING TESTING AND INSPECTION OF THE RETURNED DEVICE, IT WAS DISCOVERED THAT THERE WAS FOREIGN MATERIAL ON THE DEVICE DUE TO LACK OF PROPER REPROCESSING. THIS MEDWATCH REPORT IS BEING SUBMITTED TO CAPTURE THIS REPORTABLE MALFUNCTION WHICH WAS IDENTIFIED DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17495080 ↗
• MalfunctionApr 27, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED, THE BIOPSY FORCEPS HAD A PROBLEM WITH OPENING AND CLOSING THE CUP, WHEN BEING INSPECTED BEFORE USE IN AN UNSPECIFIED PROCEDURE. THE FORCEPS WAS NOTED TO HAVE BEEN USED 2-3 TIMES SINCE BEING RECEIVED BY THE CUSTOMER IN OCTOBER 2022. THE FORCEPS WAS REPROCESSUED USING AUTOCLAVE STERILIZATION SINCE THE SITE DID NOT HAVE ULTRASONIC CLEANING AVAILABLE. AFTER USE, THE FORCEPS WAS CLEANED, STERILZED AND STORED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823472 ↗
• MalfunctionMar 6, 2023Contamination; Contamination

  IT WAS REPORTED THE CONNECTION BETWEEN THE DEVICE CUP AND THE WIRE CAME OFF, AND THE CUP COULD NOT BE OPENED OR CLOSED. THE REPORTED ISSUE OCCURRED AT PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED ISSUE. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED . DEVICE EVALUATION , FOREIGN MATERIAL (BROWN FOREIGN MATERIAL ) AS DESCRIBED BY SERVICE REPAIR FOUND AROUND THE BROKEN ARMS OF THE DEVICE. THIS REPORT IS BEING SUBMITTED DUE TO THE FINDING OF FOREIGN MATERIAL AROUND THE BROKEN ARMS OF THE DEVICE IDENTIFIED DURING DEVICE RETURN EVALUATION .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483741 ↗
• MalfunctionMar 3, 2023Break; Contamination; Material Twisted/Bent; Break; Contamination; Material Twisted/Bent

  AS REPORTED , THE CUP OF FB-21K-1 WAS BROKEN (BENT) DURING THE PRE-USE INSPECTION. ACCORDING TO THE REPORT, THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE (DIAGNOSTIC) WAS COMPLETED USING A SIMILAR DEVICE. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483148 ↗
• MalfunctionDec 21, 2022Device Reprocessing Problem; Device Reprocessing Problem

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THAT THE REUSABLE BIOPSY FORCEPS WAS REPROCESSED WITHOUT USING AN ULTRASONIC CLEANER AS REQUIRED. INSTEAD, THE FORCEPS WAS REPORTEDLY IMMERSED IN ENDOFRESH AND THEN IN GLUTARALDEHYDE. IT WAS CONFIRMED THAT THE USER FACILITY KNEW THAT THE DEVICE NEEDED TO BE CLEANED BY IMPLEMENTING ULTRASONIC CLEANING. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE OCCURRED DURING REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030577 ↗
• MalfunctionDec 6, 2022Device Contamination with Chemical or Other Material; Failure to Clean Adequately; Device Contamination with Chemical or Other Material; Failure to Clean Adequately

  ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS EVENT. THE INTENDED PROCEDURE WAS A DIAGNOSTIC BIOPSY. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE WITHOUT ANY DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924105 ↗
• MalfunctionSep 9, 2022Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE DEVICE CUP FELT LIKE IT WAS DIFFICULT TO OPEN DURING THE EXAMINATION (UNSPECIFIED EXAMINATION). THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. DEVICE CLEANING, DISINFECTION, AND STERILIZATION (CDS) INFORMATION NOTED THAT THERE IS NO ULTRASONIC CLEANER AND INSTEAD, A NEUTRAL DETERGENT WAS USED FOR CLEANING. THE FACILITY STERILIZATION IS UNKNOWN. NO LUBRICATION NOTED. DEVICE EVALUATION FOUND THE ARMS OF THE CUPS (THE LINKAGE MECHANISM AT THE DISTAL END) HAD FOREIGN MATERIALS. THIS REPORT IS BEING SUBMITTED DUE TO DEVICE REPROCESSING ISSUE (NO ULTRASONIC CLEANER USED ON THE DEVICE DURING REPROCESSING, ARMS OF THE CUPS HAD FOREIGN MATERIALS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15389348 ↗
• MalfunctionAug 8, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING AN EXAMINATION (BIOPSY PROCEDURE) , THE RAW FORCEPS DID NOT CLOSE AND COULD NOT BE PULLED OUT OF THE SCOPE. THE BASE OF THE HANDLE OF THE BIOPSY FORCEPS WAS THEN CUT USING NIPPERS AND WAS PULLED OUT SAFELY FROM THE SCOPE . ACCORDING TO THE REPORTER, THE BIOPSY PROCEDURE WAS COMPLETED AND THERE WAS NO PROBLEM. NO HEALTH HAZARD HAS OCCURRED. THERE WAS NO PATIENT HARM , NO USER INJURY REPORTED DUE TO THIS EVENT. THIS REPORT IS BEING SUBMITTED FOR FORCEPS DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188522 ↗
• MalfunctionMay 9, 2022Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately

  A USER FACILITY SUBMITTED REQUEST TO OLYMPUS, INQUIRING INFORMATION ON THE CORRECT FLOW FOR THE CLEANING, THE DISINFECTION, AND THE STERILIZATION PROCESSES (CDS) FOR REUSE BIOPSY FORCEPS. UPON REVIEW OF THE USER FACILITY CDS FLOW LIST FOR REUSE BIOPSY FORCEPS, IT WAS DETERMINED THAT THE FACILITY WAS INCORRECTLY REPROCESSING THE DEVICE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE POSSIBLE INCORRECT REPROCESSING OF REUSE BIOPSY FORCEPS. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342367 ↗
• MalfunctionMar 15, 2022Microbial Contamination of Device; Microbial Contamination of Device

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING PREPARATION FOR USE FOR A DIAGNOSTIC GASTRIC DUODENAL FIBERSCOPY, THE CUP ON THE BIOPSY FORCEPS DID NOT OPEN AND CLOSE SMOOTHLY (POOR MESHING). THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE AND NO SURGICAL DELAY. THE PHYSICIAN IN CHARGE THOUGHT THAT THE PERFORMANCE DETERIORATED DUE TO AGING. DURING THE EVALUATION OF THE DEVICE, IT WAS NOTED FOREIGN MATTER (ENVIRONMENTAL BACTERIA) ADHERED TO THE FORCEPS. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION OF FOREIGN MATTER (ENVIRONMENTAL BACTERIA) ADHERED TO THE FORCEPS NOTED AT ESTIMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13768690 ↗
• MalfunctionNov 4, 2021Residue After Decontamination; Residue After Decontamination

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE CUP DOES NOT OPEN EVEN IF THE SLIDER IS OPERATED AT PREPARATION FOR USE. THE PRODUCT HAS BEEN USED ONLY A FEW TIMES. THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE OMSC CONFIRMED THE FOLLOWING EVENT ON (B)(6) 2021 AND DETERMINED THAT IT WAS AN MEDICAL DEVICE REPORT (MDR) REPORTABLE EVENT. CUP OPENING / CLOSING FAILURE DUE TO FOREIGN MATTER. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750278 ↗