OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 (UDI 04953170339264)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04953170339264), received between Nov 19, 2021 and Nov 4, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (8 reports).

4 FDA recall records name this device's identifier, 4 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. Sep 11, 2025Class IOpen, Classified

   Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

   Z-0047-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Oct 12, 2023Class IOpen, Classified

   There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

   Z-0189-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Jul 27, 2023Class IIOpen, Classified

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

   Z-2490-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

4. Jun 8, 2023Class IOpen, Classified

   There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

   Z-2011-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOFIBERSCOPE EXHIBITED THE PLASTIC DISTAL END COVER BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604546 ↗
• MalfunctionMar 29, 2024Melted; Melted

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED THE DISTAL END CAP HAVING BURN MARKS EVIDENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006051 ↗
• MalfunctionOct 23, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES BRONCHOFIBERSCOPE HAD WATER LEAKAGE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE COATING OF THE IMAGE GUIDE PIPE WAS PEELING OFF. (1MM2 OR MORE). 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 17993175 ↗
• MalfunctionSep 29, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES BRONCHOFIBERSCOPE TESTED POSITIVE FOR MICROBIAL CONTAMINATION. THE ISSUE WAS FOUND AT REPROCESSING DURING A ROUTINE CULTURE OF THE SCOPE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840930 ↗
• MalfunctionJul 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THE OES BRONCHOFIBERSCOPE, INSULATION AT THE DISTAL END HAS COME LOOSE. THE ISSUE WAS FOUND DURING THE REPROCESSING. THERE WAS NO PROCEDURE INVOLVED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260728 ↗
• MalfunctionJun 19, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THE OES BRONCHOFIBERSCOPE LIGHT DOES NOT TURN ON, OR SWITCH OFF. IT IS UNKNOWN WHEN THE EVENTS TOOK PLACE. SUBSEQUENTLY DURING INSPECTION FROM THE OLYMPUS STAFF, IT WAS DISCOVERED THE COAT ON THE IMAGE GUIDE SNAKE PIPE IS PEELING OFF. 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 17155487 ↗
• MalfunctionJun 6, 2023Separation Problem; Separation Problem

  THE CUSTOMER REPORTED TO OLYMPUS, A BENDING SECTION COVER WAS PEELING ON THE OES BRONCHOFIBERSCOPE. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS FOUND THAT THE BENDING SECTION COVER WAS FALLING OFF THE DEVICE. 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 17074826 ↗
• MalfunctionFeb 13, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, LEAKAGE AT THE EYEPIECE OF BRONCHOFIBERSCOPE WAS NOTED DURING REPROCESSING. THE DEVICE WAS RETURNED AND AN EVALUATION AT THE REPAIR CENTER REVEALED, THE SUBJECT DEVICE WAS REPROCESSED IN THE SAME REPROCESSOR AS THE ENDOSCOPE WITH A CONFIRMED CREUTZFELDT-JACOB DISEASE (CJD) CONTAMINATION. THIS REPORT IS BEING SUBMITTED TO CAPTURE SUSPICION OF CJD FOUND DURING DEVICE EVALUATION. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT. PATIENT IDENTIFIER # (B)(6) CAPTURES COMPLAINT ON THE SCOPE WITH CJD CONTAMINATION (MODEL: BF-1TH190, MODEL DESCRIPTION:EVIS EXERA III BRONCHOVIDEOSCOPE, SERIAL NO. (B)(4) ).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362480 ↗
• MalfunctionFeb 8, 2023Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER REPORTED THE OES BRONCHOFIBERSCOPE HAD AIR/WATER LEAKS. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE INDICATION ON THE CONNECTING TUBE HAD DISAPPEARED AREA. THE REPORT IS BEING SUBMITTED DUE TO INDICATION DISAPPEARING ON THE CONNECTING TUBE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16322014 ↗
• MalfunctionDec 28, 2022Break; Break

  THE ISSUE WAS FOUND DURING REPROCESSING FOLLOWING A DIAGNOSTIC SPUTUM ASPIRATION TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061217 ↗
• MalfunctionSep 6, 2022Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED DURING A REPROCESSING IN-SERVICE VISIT, THE ENDOSCOPY SUPPORT SPECIALIST FOUND THAT THE CUSTOMER DOES NOT HAVE A SUCTION SOURCE AND ARE NOT ABLE TO FOLLOW THE REPROCESSING INSTRUCTION OF THE DEVICE AS INDICATED IN THE REPROCESSING MANUAL. THERE IS NO PATIENT INFECTION ASSOCIATED ON THIS REPORTED EVENT. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15359059 ↗
• MalfunctionJul 23, 2022Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY SUBMITTED A REPAIR REQUEST TO THE OLYMPUS SERVICE CENTER, ON AN OES BRONCHOFIBERSCOPE FOR LEAKING TIP. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, THE SCOPE IMAGE GUIDE SERPENTINE COAT WAS FOUND PEELING OFF (1-2MM OR MORE). 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 15090385 ↗
• MalfunctionJul 14, 2022Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY SUBMITTED A REPAIR REQUEST TO THE OLYMPUS SERVICE CENTER, FOR THE OES BRONCHOFIBERSCOPE FOR LEAKING AT THE INSERTION PART TUBE. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, THE COATING OF THE INSERTION GUIDE SERPENTINE TUBE WAS FOUND PEELED OFF. (1 TO 2 MM OR MORE). THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021034 ↗
• MalfunctionApr 4, 2022Peeled/Delaminated; Peeled/Delaminated

  OLYMPUS (OMSC) WAS INFORMED THAT THE CUSTOMER BRONCHO-FIBERSCOPE WAS RETURNED FOR SERVICE/REPAIR FOR A REPORTED ¿LEAK¿ FOUND DURING AN UNSPECIFIED EVENT. HOWEVER, UPON INSPECTING AND TESTING, THE COATING OF THE INSERTION TUBE WAS FOUND PEELING OFF. THE REPORTABLE DEFECT WAS FOUND DURING SERVICE INSPECTION. NO DEATH, INJURY OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13997539 ↗
• MalfunctionFeb 24, 2022Contamination; Contamination

  A USER FACILITY REPORTED THAT THE COLOR OF THE CH-TUBE INNER WALL OF THE SUBJECT BRONCHOFIBERSCOPE WAS ABNORMAL. THE FAULT WAS IDENTIFIED DURING RECEIPT INSPECTION. A SIMILAR DEVICE WAS USED TO COMPLETE THE INTENDED PROCEDURE. DURING A STANDARD SERVICE INSPECTION OF THE CUSTOMER RETURNED DEVICE, BLACK MATERIAL ON THE INNER WALL WAS NOTED. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION FOUND AT RECEIPT INSPECTION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592390 ↗
• MalfunctionFeb 15, 2022Fluid/Blood Leak; Peeled/Delaminated; Fluid/Blood Leak; Peeled/Delaminated

  A USER FACILITY RETURNED THE OLYMPUS, THE OES BRONCHO FIBER VIDEOSCOPE TO THE SERVICE CENTER DUE TO A LEAKAGE IN THE BENDING SECTION COVER . UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THE BENDING MANIPULATION AND INSERTION TUBE WAS DEFECTIVE WITH PEELING OF THE COATING FROM THE INSERTION SECTION. THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13536858 ↗
• MalfunctionJan 24, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THE BENDING SECTION COVER OF THE SCOPE WAS LEAKING AND THERE WERE BLACK SPOTS ON THE IMAGE. THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE COATING OF THE INSERTION SECTION WAS PEELING. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (COATING WAS PEELING). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13337857 ↗
• MalfunctionJan 11, 2022Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY REPORTED TO OLYMPUS THE OES BRONCHOFIBERSCOPE WAS LEAKING AT THE BENDING SECTION AFTER A PROCEDURE. USER CONFIRMED THERE WAS NO HARM OR USER INJURY DUE TO THE EVENT. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, IT WAS OBSERVED THAT THE CONNECTING TUBE COATING WAS PEELING OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13226230 ↗
• MalfunctionNov 19, 2021Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES BRONCHOFIBERSCOPE TESTED POSITIVE FOR A MICROBIAL CONTAMINATION. THE ISSUE WAS FOUND DURING ROUTINE CULTURING OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843718 ↗