OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XP60 (UDI 04953170339240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 04953170339240), received between Feb 16, 2022 and Nov 14, 2024 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (41 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-2491-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THE BRONCHOFIBERSCOPE HAD IMAGE PROBLEM. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683339 ↗
• MalfunctionNov 11, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OES BRONCHOFIBERSCOPE EXHIBITED THE COATING PEELING ON THE CONNECTING TUBE . THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652109 ↗
• MalfunctionSep 12, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207393 ↗
• MalfunctionSep 6, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOFIBERSCOPE EXHIBITED THAT INSERTION SECTION SOFT TUBE COATING WAS PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157992 ↗
• MalfunctionSep 6, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED THE INSERTION SECTION SOFT TUBE COATING PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156742 ↗
• MalfunctionAug 19, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999409 ↗
• MalfunctionAug 5, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19914524 ↗
• MalfunctionMay 15, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOFIBERSCOPE EXHIBITED INSERTION SECTION FLEXIBLE TUBE COATING PEELING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319171 ↗
• MalfunctionApr 7, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057002 ↗
• MalfunctionMar 22, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOFIBERSCOPE CONNECTING TUBE COATING EXHIBITED PEELING (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960719 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE CONNECTING TUBE COATING WAS PEELING OFF (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839715 ↗
• MalfunctionJan 31, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED THE CONNECTING TUBE WITH COATING PEELING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18620041 ↗
• MalfunctionDec 21, 2023Break; Peeled/Delaminated; Break; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE BRONCHOFIBERSCOPE HAD AN AIR/WATER LEAKAGE ISSUE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE COATING OF THE IMAGE GUIDE PIPE WAS PEELING OFF (1MM TO 2MM). THE RESIN PART OF THE IMAGE GUIDE COIL HAD ALSO FALLEN 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 18378897 ↗
• MalfunctionDec 19, 2023Peeled/Delaminated; Failure to Clean Adequately; Peeled/Delaminated; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE BRONCHOFIBERSCOPE WAS CLOUDY. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING WAS FOUND: THE PLASTIC DISTAL END AND THE ADHESIVE ON THE BENDING SECTION COVER HAD FOREIGN OBJECTS, AND THE CONNECTING TUBE HAD COATING PEELING. 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 18358507 ↗
• MalfunctionDec 19, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BRONCHOFIBERSCOPE HAD A CLOUDY IMAGE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE IMAGE GUIDE TUBE COATING WAS PEELING. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355993 ↗
• MalfunctionDec 12, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES BRONCHOFIBERSCOPE HAD POOR VISIBILITY WITH A CLOUDY TIP. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION AND DURING THE EVALUATION THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE IMAGE GUIDE CABLE COAT WAS 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 18314228 ↗
• MalfunctionDec 4, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BRONCHOFIBERSCOPE HAD WATER LEAKAGE ON THE CURVED PART. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE EVENT WAS FOUND: THE COATING OF THE IMAGE GUIDE PIPE WAS PEELING OFF. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263177 ↗
• MalfunctionNov 28, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES BRONCHOFIBERSCOPE HAD COMPROMISED IMAGE (BLUR/ABNORMAL COLOR TONE/PARTIAL LOSS OF IMAGE). IT IS UNKNOW WHEN THE ISSUE WAS FOUND. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND; DETERIORATION (BENDING MANIPULATION AND INSERTION TUBE DEFECTS). 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 18222072 ↗
• MalfunctionOct 15, 2023Peeled/Delaminated; Peeled/Delaminated

  THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE OES BRONCHOFIBERSCOPE WAS INSPECTED BEFORE USE AND HAD AN AIR AND WATER LEAKAGE. THERE WERE NO REPORTS OF PATIENT HARM. DURING EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE CONNECTING TUBE HAD COATING PEELING OF AT LEAST 1 SQUARE MILLIMETER AND THEREFORE IS CONSIDERED A MEDICAL DEVICE REPORT (MDR). THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936920 ↗
• MalfunctionOct 9, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES BRONCHOFIBERSCOPE HAD ¿ANGLE DOWN.¿ THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND, ¿THE COAT OF THE IMAGE GUIDE PIPE 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 17902171 ↗
• MalfunctionOct 5, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES BRONCHOFIBERSCOPE HAD CREASES AND PEELING. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE IMAGE GUIDE SNAKE PIPE COATING WAS 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 17881105 ↗
• MalfunctionJul 28, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THE OES BRONCHOFIBERSCOPE HAD A VENT METAL AIR LEAK. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT. UPON DEVICE RETURN AND EVALUATION, IT WAS OBSERVED THAT THE COATING ON THE CONNECTING TUBE HAS PEELING WHICH IS A REPORTABLE 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 17417590 ↗
• MalfunctionJul 26, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES BRONCHOFIBERSCOPE HAD A SUNSPOT IN THE FIELD OF VIEW. DURING INSPECTION AND EVALUATION, THE COAT ON THE IMAGE GUIDE SNAKE PIPE IS PEELING OFF. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING INCOMING INSPECTION AND EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17394957 ↗
• MalfunctionJul 11, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES BRONCHOFIBERSCOPE TESTED POSITIVE MICROBIAL CONTAMINATION. THE SCOPE WAS SAMPLED TWICE. DURING THE FIRST SAMPLING, THE SCOPE TESTED POSITIVE FOR 2 COLONY FORMING UNITS (CFUS) OF UNSPECIFIED AEROBIC MICROORGANISMS. DURING THE SECOND SAMPLING, THE SCOPE TESTED POSITIVE FOR 1 CFUS OF OCHROBACTRUM ANTHROPI. THE ISSUE WAS FOUND AT REPROCESSING DURING A ROUTINE CULTURE OF THE SCOPE. ALL CHANNELS WERE TESTED. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302350 ↗
• MalfunctionJul 7, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS A LEAKAGE ISSUE WHILE USING THE OES BRONCHOFIBERSCOPE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND THE COATING OF THE IG SERPENTINE WAS PEELING OFF. (1MM2 OR MORE). THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279714 ↗