BIOPSY FORCEPS FB-19K-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170029608), received between Apr 13, 2022 and Jul 24, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BIOPSY FORCEPS EXHIBITED PROBLEMS CAUSED BY IMPROPER REPROCESSING (FOREIGN MATTER). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816380 ↗
• MalfunctionDec 4, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE BIOPSY FORCEPS WERE NOT OPENING OR CLOSING. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, FOREIGN MATERIAL WAS FOUND IN THE GRASPING CUPS PREVENTING IT FROM OPENING AND CLOSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257761 ↗
• MalfunctionJul 27, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE BIOPSY FORCEPS HANDLE DID NOT MOVE AND THE CUP DID NOT OPEN WHEN TRYING TO SLIDE THE HANDLE. THE REPORTED ISSUE OCCURRED DURING PREPARATION OF USE FOR AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT. UPON DEVICE RETURN AND EVALUATION, IT WAS OBSERVED THAT THERE WAS FOREIGN MATERIAL THAT ADHERED TO THE LINKAGE MECHANISM AND TO THE INSIDE OF THE CUP WHICH IS IDENTIFIED AS A REPORTABLE EVENT PER THE RISK SUMMARY APPLICATION (RSA). THE NEW AWARE DATE FOR THIS REPORTABLE MALFUNCTION IS (B)(6) 2023. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406948 ↗
• MalfunctionJun 29, 2023Contamination /Decontamination Problem; Failure to Clean Adequately; Contamination /Decontamination Problem; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BIOPSY FORCEPS EXHIBITED SLOW CUP MOVEMENT. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, FOREIGN MATERIAL WAS FOUND ADHERED TO THE LINKAGE MECHANISM DUE TO INSUFFICIENT CLEANING. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT AFTER CLEANING/STERILIZING, THE ACTUAL PRODUCT WAS STORED FOR USE IN THE NEXT CASE AND BECAUSE THE PREVIOUS CASE DID NOT WORK WELL, THE CUSTOMER CHECKED THE OPERATION OF THE CUP, AND DISCOVERED THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226005 ↗
• MalfunctionOct 1, 2022Contamination; Failure to Clean Adequately; Contamination; Failure to Clean Adequately

  CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR FOR THE CUP AT THE TIP BEING BROKEN DURING REPROCESSING AFTER FIRST TIME USE OF THE DEVICE. THERE IS NO PATIENT INVOLVEMENT. THE PREVIOUS BIOPSY PROCEDURE WAS SUCCESSFULLY COMPLETED. THE REPROCESSING HAD BEEN PERFORMED BY IMMERSION IN DISINFECTANT, IMMERSION TIME AND DISINFECTANT TYPE IS UNKNOWN. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE ARM OF THE CUP (A PART OF THE LINKAGE MECHANISM AT THE DISTAL END) WERE BROKEN. THE BROKEN ARMS HAD BROWN FOREIGN MATERIALS AROUND THE BROKEN PLACE. THE BROKEN ARMS WERE NOT MISSING. THIS MEDWATCH IS BEING SUBMITTED FOR THE FOREIGN MATERIAL FOUND ON THE DEVICE DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15522894 ↗
• MalfunctionSep 13, 2022Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE BIOPSY FORCEPS, THE CUPS COULD NO LONGER BE OPENED AND CLOSED, AFTER BEING USED SEVERAL TIMES SINCE THEY WERE BRAND NEW. THE ISSUE WAS FOUND AT PREPARATION FOR USE, THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND FOREIGN MATERIAL WAS FOUND ADHERING TO THE FORCEPS. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414913 ↗
• MalfunctionJun 14, 2022Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED THAT, DURING PREPARATION FOR USE, THERE WAS A CATCH WHEN THE SLIDER WAS MOVED BACK AND FORTH DURING THE PRE-CASE INSPECTION. THE CUP OPENED AND CLOSED, BUT THERE WAS A CATCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THE SUBJECT DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, FOREIGN MATTER WAS FOUND ON THE FORCEPS. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (FOREIGN MATERIAL). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14690003 ↗
• MalfunctionJun 6, 2022Contamination; Difficult to Open or Close; Contamination; Difficult to Open or Close

  THE CUSTOMER REPORTED THE BIOPSY FORCEPS CUP FAILED TO OPEN. THE EVENT OCCURRED DURING PREPARATION FOR USE AND A SIMILAR DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606658 ↗
• MalfunctionMay 18, 2022Contamination; Contamination

  A USER FACILITY REPORTED THAT THE BIOPSY FORCEPS CUP FAILED TO OPEN. THE EVENT OCCURRED DURING PREPARATION FOR USE AND A SIMILAR DEVICE WAS USED TO COMPLETE THE OPERATION. DURING A STANDARD SERVICE INSPECTION OF THE CUSTOMER RETURNED DEVICE, FOREIGN MATTER WAS ADHERED TO THE FORCEPS. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION FOUND AT INSPECTION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427387 ↗
• MalfunctionApr 13, 2022Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER ORIGINALLY RETURNED HIS OLYMPUS BIOPSY FORCEPS AS DURING AN UPPER ENDOSCOPY CASE, THE CUPS WOULD NOT CLOSE. ACCORDING TO THE INITIAL REPORTER, THE FORCEPS AND SCOPE WERE BOTH REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER SET OF FORCEPS WITH NO PATIENT HARM REPORTED. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE BIOPSY FORCEPS HAD EXPERIENCED A REPROCESSING ISSUE CAUSING THEM TO RUST. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPROCESSING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104958 ↗