OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 3C40 (UDI 04953170339219)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04953170339219), received between Sep 10, 2021 and Feb 7, 2025 — classified as 12 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (28 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Jul 27, 2023Class IIOpen, Classified

   Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

   Z-2502-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT DURING REPROCESSING, THE FLEXIBLE SCOPE DID NOT PASS STERILIZATION, TESTED ON 3 DIFFERENT STERILIZERS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337159 ↗
• MalfunctionOct 23, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE BRONCHOFIBERSCOPE COATING OF IG HOSE PEELED OFF (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517511 ↗
• MalfunctionOct 23, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED, DURING DEVICE EVALUATION. THAT THE COATING ON THE IMAGE GUIDE HOSE OF THE BRONCHOFIBERSCOPE WAS PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513143 ↗
• MalfunctionAug 21, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE COATING OF LIGHT GUIDE HOSE ON THE OES BRONCHOFIBERSCOPE HAD PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020495 ↗
• MalfunctionMar 25, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOFIBERSCOPE EXHIBITED FOREIGN OBJECTS IN THE ANGULATION LEVER. 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 18968817 ↗
• MalfunctionMar 25, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOFIBERSCOPE EXHIBITED PEELING OF COATING OF THE IMAGE GUIDE PIPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968192 ↗
• MalfunctionMar 23, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOFIBERSCOPE EXHIBITED FOREIGN MATERIAL ON THE BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965482 ↗
• MalfunctionFeb 5, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE BRONCHOFIBERSCOPE IMAGED LOOKED BLURRY. THE DEVICE WAS RETURNED FOR EVALUATION. DURING TESTING AND INSPECTION OF THE DEVICE, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: LIGHT GUIDE LENS HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. 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 18643853 ↗
• MalfunctionDec 21, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES BRONCHOFIBERSCOPE HAS FALLEN RUBBER AT THE DISTAL END, TIGHTENED UPPER SHEATH. THIS ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED BY USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376003 ↗
• MalfunctionDec 12, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE BRONCHOFIBERSCOPE HAD SCRATCHES ON THE UNIVERSAL CORD, MEANDERING OF THE INSERTION PART, DISCOLORATION OF THE CONNECTOR AND OPERATION PARTS. THE DEVICE WAS RETURNED FOR EVALUATION. DURING TESTING AND INSPECTION OF THE DEVICE, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: COAT OF THE IMAGE GUIDE PIPE WAS PEELING OFF (1X1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. 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 18311714 ↗
• MalfunctionNov 29, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE OES BRONCHOFIBERSCOPE HAD A WATER LEAK. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT INSERTION SECTION FLEXIBLE TUBE COATING WAS PEELING OFF. 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 18233761 ↗
• MalfunctionOct 27, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER ORIGINALLY RETURNED HIS OLYMPUS OES BRONCHOVIBERSCOPE DUE TO AN ANGULATION MALFUNCTION. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE COATING MATERIAL WAS PEELING. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE PEELING COATING MATERIAL FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021379 ↗
• MalfunctionOct 19, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES BRONCHOFIBERSCOPE HAD PEELING OFF/STICKINESS OF THE INSERTION PART COATING AND SEPARATION. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE IMAGE GUIDE PIPE WAS PEELING OFF. 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 17965972 ↗
• MalfunctionSep 20, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES BRONCHOFIBERSCOPE EPERIENCED AIR/WATER LEAKAGES. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE INSERTION PART COATING PEELING OFF. 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 17781023 ↗
• MalfunctionSep 8, 2023Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY SUBMITTED A REPAIR REQUEST TO THE OLYMPUS SERVICE CENTER, FOR AN OES BRONCHOFIBERSCOPE PROTECTOR OF UNIVERSAL CORD ON SCOPE CONNECTOR SIDE DAMAGED. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, THE SCOPE INSERTION PART COATING WAS FOUND PEELED OFF. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715768 ↗
• MalfunctionSep 8, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER INITIALLY REPORTED DEFECTS IN RUBBER ON THE OES BRONCHOVIDEOSCOPE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: THE COAT OF THE IG SERPENTINE IS PEELED OFF. 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 17710868 ↗
• MalfunctionAug 29, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT WHEN USING AN OES BRONCHOFIBERSCOPE THERE WAS A LEAKAGE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND UPON ESTIMATION, THE CONNECTING TUBE HAD COATING PEELING (1MM2 OR MORE). THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642239 ↗
• MalfunctionAug 23, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED OLYMPUS THAT THE OES BRONCHOFIBERSCOPE HAD LEAK. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: PEELING OF THE COATING IN THE INSERTION PART OF THE CONNECTING TUBE (1MM SQUARED OR MORE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607404 ↗
• MalfunctionJul 7, 2023Degraded; Peeled/Delaminated; Degraded; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THERE WERE DEFECTS OF THE BENDING SECTION AND INSERTION TUBE ON THE OES BRONCHOFIBERSCOPE. DURING INSPECTION AND TESTING OF THE RETURNED DEVICE IT WAS FOUND THAT THE CONNECTING TUBE HAD COATING THAT WAS PEELING. THERE WAS NO REPORT OF DELAY OR HARM TO A PATIENT OR USER. 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 17279346 ↗
• MalfunctionJun 27, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE BENDING OPERATION OF THE OES BRONCHOFIBERSCOPE WAS DISABLED. THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE WAS RETURNED, EVALUATED. AND THE IT WAS FOUND, THAT THE COATING OF THE IMAGE GUIDE SERPENTINE WAS PEELING OFF (1MM2 OR MORE). THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209517 ↗
• MalfunctionJun 7, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO OLYMPUS, THAT THE OES BRONCHOFIBERSCOPE HAD ANGULATION MALFUNCTION. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THAT THE CONNECTING TUBE COATING WAS PEELING. THERE WERE NO REPORTS HARM ASSOCIATED WITH THE EVENT. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080828 ↗
• MalfunctionMay 5, 2023Peeled/Delaminated; Peeled/Delaminated

  A DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER, THAT THEIR OES BRONCHOFIBERSCOPE HAD AN ANGULATION MALFUNCTION. UPON INSPECTION AND TESTING OF THE RETURNED UNIT, IT WAS DISCOVERED, THAT THE COATING OF THE CONNECTING TUBE WAS PEELING. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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 16881222 ↗
• MalfunctionApr 25, 2023Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY SUBMITTED A REPAIR REQUEST TO THE OLYMPUS SERVICE CENTER, FOR A CYSTO-NEPHRO VIDEOSCOPE, HAVING AIR/WATER LEAKING FROM THE SCOPE ANGLE RUBBER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, COATING ON THE SCOPE IMAGE GUIDE SNAKE TUBE WAS FOUND PEELING. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811529 ↗
• MalfunctionMar 10, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES BRONCHOFIBERSCOPE HAD A PINHOLE SIZE IN THE COIL. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE SUBJECT DEVICE AS SUBSEQUENTLY EVALUATED BY OLYMPUS AND THE COATING ON THE INSERTION SECTION OF THE TUBE WAS FOUND TO BE PEELING. 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 16523989 ↗
• MalfunctionMar 3, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, DURING AN UNSPECIFIED PROCEDURE, AN ANGULATION ISSUE OCCURRED ON THE OES BRONCHOFIBERSCOPE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING EVALUATION OF THE RETURNED DEVICE, THE EVALUATION FOUND THAT THE COATING OF THE IG SERPENTINE IS PEELING OFF BY 1 - 2 MM OR MORE. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479467 ↗