EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 (UDI 04953170339301)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170339301), received between Jul 22, 2020 and Apr 10, 2023 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 reports).

2 FDA recall records name this device's identifier, 2 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-0061-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Jun 8, 2023Class IOpen, Classified

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

   Z-2016-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2023Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A USER FACILITY MEDWATCH (B)(4), WHICH REPORTED THAT DURING A DIAGNOSTIC BRONCHOSCOPY USING AN OLYMPUS BRONCHOSCOPE WITH YAG LASER PROCEDURE USING A NON-OLYMPUS LASER MACHINE AND FIBERS, A FIRE STARTED INSIDE THE NON-OLYMPUS ENDOTRACHEAL TUBE (ETT) DURING LASER ABLATION OF A CARINAL TUMOR. THE TIP OF THE LASER FIBER WAS BURNED OFF AND APPARENTLY LOST IN THE PATIENT. A PORTION OF THE ETT BURNED AND MELTED BOTH THE BRONCHOSCOPE AND THE END OF THE FIBER. BRONCHOSCOPY FOLLOWING THE FIRE WAS DIFFICULT TO ASSESS, AS THERE HAD BEEN EXTENSIVE LASER TREATMENT FULGURATION PRIOR TO THE FIRE. THE FIRE WAS QUICKLY EXTINGUISHED AND THE PATIENT APPEARED TO HAVE SUSTAINED MINOR INJURY ONLY. IT WAS NOT CLEAR IF THE FIBER FAILED FIRST AND CAUGHT THE ETT ON FIRE OR IF THE FIRE STARTED FIRST AND MELTED THE FIBER. LASER POWER WAS SET AT 15 WATTS WITH A DURATION OF 0.5 SECONDS. THE LASER WAS 1064 NM WAVELENGTH. THE LASER MACHINE WAS TESTED FOLLOWING THE INCIDENT AND THE POWER OUTPUT WAS FOUND WITHIN ALLOWABLE TOLERANCE. THE DISTAL END OF THE DAMAGED FIBERS APPEARED TO BE FRACTURED, BUT IT WAS NOT KNOWN AT WHAT POINT THAT THIS OCCURRED. THE FIBER USED WAS A C

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16710561 ↗
• InjuryApr 10, 2023Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A USER FACILITY MEDWATCH (B)(4), WHICH REPORTED THAT DURING A DIAGNOSTIC BRONCHOSCOPY USING AN OLYMPUS BRONCHOSCOPE WITH YAG LASER PROCEDURE USING A NON-OLYMPUS LASER SYSTEM, A FIRE STARTED INSIDE THE NON-OLYMPUS ENDOTRACHEAL TUBE (ETT) DURING LASER ABLATION OF A CARINAL TUMOR. THE TIP OF THE LASER FIBER WAS BURNED OFF AND APPARENTLY LOST IN THE PATIENT. A PORTION OF THE ETT BURNED AND MELTED BOTH THE BRONCHOSCOPE AND THE END OF THE FIBER. BRONCHOSCOPY FOLLOWING THE FIRE WAS DIFFICULT TO ASSESS, AS THERE HAD BEEN EXTENSIVE LASER TREATMENT FULGURATION PRIOR TO THE FIRE. THE FIRE WAS QUICKLY EXTINGUISHED AND THE PATIENT APPEARED TO HAVE SUSTAINED MINOR INJURY ONLY. IT WAS NOT CLEAR IF THE FIBER FAILED FIRST AND CAUGHT THE ETT ON FIRE OR IF THE FIRE STARTED FIRST AND MELTED THE FIBER. LASER POWER WAS SET AT 15 WATTS WITH A DURATION OF 0.5 SECONDS. THE LASER WAS 1064 NM WAVELENGTH. THE LASER MACHINE WAS TESTED FOLLOWING THE INCIDENT AND THE POWER OUTPUT WAS FOUND WITHIN ALLOWABLE TOLERANCE. THE DISTAL END OF THE DAMAGED FIBERS APPEARED TO BE FRACTURED, BUT IT WAS NOT KNOWN AT WHAT POINT THAT THIS OCCURRED. THE FIBER USED WAS A CONTACT TYPE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16710540 ↗
• MalfunctionDec 9, 2021Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT DURING MAINTENANCE THE SCOPE FAILED THE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THE DEVICE WAS RETURNED FOR EVALUATION AND FOUND EXCESSIVE PEELING ON THE NON-OLYMPUS INSERTION TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12970912 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED THAT A-RUBBER WAS BLOWN OFF THE DISTAL END OF A EVIS EXTERA II BRONCHOVIDEOSCOPE DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR USER INJURY REPORTED DUE TO THE EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694693 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED 19 DAYS POST BRONCHOSCOPY PROCEDURE FOR THE INDICATION OF HEMOPTYSIS FOR TWO MONTHS AND COUGH, USING AN EVIS EXERA II BRONCHOVIDEOSCOPE, THE PATIENT DEVELOPED A RESPIRATORY TRACT INFECTION WITH MYCOBACTERIUM LLATZERENSE. THIS WAS DIAGNOSED WITH BRONCHIAL ALVEOLAR LAVAGE (BAL). IT IS UNKNOWN WHAT TREATMENT THE PATIENT REQUIRED AS A RESULT OF THIS INFECTION. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11665618 ↗
• InjuryApr 14, 2021Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem

  IT IS REPORTED 19 DAYS POST BRONCHOSCOPY PROCEDURE FOR THE INDICATION OF HEMOPTYSIS FOR TWO MONTHS AND COUGH, USING AN EVIS EXERA II BRONCHOVIDEOSCOPE, THE PATIENT DEVELOPED A RESPIRATORY TRACT INFECTION WITH MYCOBACTERIUM LLATZERENSE. THIS WAS DIAGNOSED WITH BRONCHIAL ALVEOLAR LAVAGE (BAL). IT IS UNKNOWN WHAT TREATMENT THE PATIENT REQUIRED AS A RESULT OF THIS INFECTION. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Respiratory Tract Infection

  MAUDE report 11665612 ↗
• MalfunctionJan 8, 2021Crack; Fluid/Blood Leak; Peeled/Delaminated; Material Split, Cut or Torn; Crack; Fluid/Blood Leak; Peeled/Delaminated; Material Split, Cut or Torn

  IT IS REPORTED DURING REPROCESSING OF AN EVIS EXERA II BRONCHOVIDEOSCOPE, A HOLE WAS FOUND IN THE DISTAL TIP. THERE WAS NO PATIENT CONTACT/IMPACT RELATED TO THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 11141579 ↗
• MalfunctionDec 17, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER CONTACTED OLYMPUS TO REPORT THE BENDING SECTION COVER FELL OFF THE SCOPE DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11029480 ↗
• MalfunctionNov 6, 2020Microbial Contamination of Device; Microbial Contamination of Device

  THE SERVICE CENTER WAS INFORMED THAT THE SCOPE CULTURED POSITIVE MULTIPLE TIMES AFTER REPROCESSING. THE USER FACILITY REPORTED THAT THE SUCTION, BIOPSY PORT AND TIP WERE SAMPLED USING A SWAB AND CULTURED. THE MICROORGANISMS WERE DETECTED FROM THE SUCTION PORT. THE MICROORGANISM DETECTED WAS STAPH. BACILLUS AND YEAST. ON (B)(6) 2019 THERE WAS BACILLUS SPECIES GROWING ON THE SUCTION. THIS SCOPE HAD NOT BEEN USED SINCE (B)(6) 2019 WHEN IT WAS CULTURED. STAPH. AUREUS WAS PRESENT ON THE SCOPE ON (B)(6) 2020. THERE WAS NO GROWTH WITHIN FIVE DAYS AFTER THE SCOPE WAS RE-CULTURED ON (B)(6) 2020. THE SCOPE WAS REPROCESSED ON (B)(6) 2020 AND THE SUCTION CONNECTOR TESTED POSITIVE FOR YEAST ON (B)(6) 2020. THE SCOPE WAS DISINFECTED AGAIN (HLD) AND RE-CULTURED WITH NO GROWTH ON (B)(6) 2020. THE DEVICE SAMPLING AND CULTURING WERE PERFORMED AS A RANDOM MONTHLY TESTING. THE DEVICE WAS NOT USED ON A PATIENT WITH A KNOWN INFECTION OF THE SAME MICROORGANISM. NO PATIENTS WERE CULTURED AND THERE WERE NO PATIENT INFECTIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10801342 ↗
• MalfunctionOct 12, 2020Fluid/Blood Leak; Peeled/Delaminated; Material Twisted/Bent; Fluid/Blood Leak; Peeled/Delaminated; Material Twisted/Bent

  AS REPORTED FOR THIS EVENT, DURING REPROCESSING A LEAK WAS OBSERVED AT THE DISTAL END OF THE DEVICE. THERE IS NO PATIENT INVOLVEMENT AND NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10663583 ↗
• MalfunctionSep 28, 2020Failure to Clean Adequately; Failure to Clean Adequately

  THE SERVICE CENTER WAS INFORMED THAT DURING A REPROCESSING IN-SERVICE WITH AN ENDOSCOPIC SUPPORT SPECIALIST (ESS) AT THE CUSTOMER¿S SITE THE SCOPE WAS IMPROPERLY REPROCESSED. THE ESS REPORTED THAT THE FACILITY¿S STERILE PROCESSING DOES NOT PERFORM THE PRE-CLEANING STEPS. ALSO, THAT THE FACILITY WAS NOT COMPLETING SUCTION FOLLOWING THE BRUSHING OF THE SUCTION CLEANING ADAPTER. THERE WAS NO PATIENT INVOLVEMENT, PATIENT INFECTIONS OR DEVICE POSITIVE CULTURES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10597098 ↗
• MalfunctionJul 22, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A LEAKAGE FROM THE DISTAL TIP OF THE DEVICE. THE REPORTER STATED THIS WAS DISCOVERED DURING REPROCESSING OF THE DEVICE SO THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10310885 ↗