EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-ACRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04953170340086), received between Oct 16, 2019 and Feb 9, 2026 — classified as 8 injuries, 19 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (10 reports).

3 FDA recall records name this device's identifier, 3 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-0062-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 27, 2023Class IIOpen, Classified

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

   Z-2492-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

3. 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Melted

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE HAD A MELTED C-COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299919 ↗
• MalfunctionJan 21, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE DISTAL END C-COVER EXHIBITED A MISSING GLUE . THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133761 ↗
• MalfunctionJan 9, 2026Corroded; Poor Quality Image

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED INTERMITTENT FLICKER DURING MANIPULATION AND RUST WITHIN THE CHANNEL OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023663 ↗
• MalfunctionDec 29, 2025Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image

  CUSTOMER REPORTED "FAILURE OF LEAK TEST " . THE ISSUE WAS FOUND DURING REPROCESSING. EVENT DATE WAS NOT PROVIDED. THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED EVENT. DEVICE INSPECTION FOUND THE DEVICE HAD NO IMAGE, COMPLETELY ABSENT WITH DISTORTION, FLICKERING WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919395 ↗
• MalfunctionDec 19, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED INTERMIT/FLICKERING ON IMAGE WHEN ANGULATING ANGULATION-LEVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850147 ↗
• MalfunctionDec 12, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT WITH THE BRONCHOVIDEOSCOPE THERE WAS NO VIDEO. THE ISSUE OCCURRED DURING INSPECTION OF THE DEVICE FOR USE BEFORE PATIENT IN A ROOM. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789897 ↗
• MalfunctionDec 4, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE EXPERIENCED A LOST IMAGE. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23721522 ↗
• MalfunctionAug 19, 2025Contamination; Failure to Clean Adequately; Contamination; Failure to Clean Adequately

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842691 ↗
• MalfunctionAug 14, 2025No Display/Image; No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803973 ↗
• MalfunctionJun 11, 2025No Display/Image; No Display/Image

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183154 ↗
• MalfunctionApr 17, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE WAS NOT SHOWING A PICTURE WHEN PLUGGED IN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862601 ↗
• MalfunctionMar 18, 2025No Display/Image; No Display/Image

  IT WAS REPORTED, THE BRONCHOVIDEOSCOPE EXHIBITED IT¿S NOT GENERATING AN IMAGE WHEN YOU PLUG IT INTO THE LIGHTSOURCE. THE ISSUE IS UNKNOWN AS TO WHEN IT OCCURRED. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634050 ↗
• MalfunctionDec 7, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THERE WAS NO IMAGE ON THE BRONCHOVIDEOSCOPE. CUSTOMER HAD TESTED IN TWO MACHINES AND FOUND THE SAME RESULT. THE ISSUE WAS FOUND WAS DURING SET-UP OF THE SUBJECT DEVICE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288506 ↗
• MalfunctionApr 18, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II BRONCHOVIDEOSCOPE DISPLAYED A BAD IMAGE. THE DEVICE WAS RETURNED AND AN EVALUATION AT THE REPAIR CENTER REVEALED, THE SCOPE DISPLAYED NO IMAGE AFTER AUOCLAVE. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761883 ↗
• MalfunctionJan 17, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THE VIDEO OF THE EVIS EXERA II BRONCHOVIDEOSCOPE WAS INTERMITTENT AND DROPPED OUT WHEN THE SCOPE WAS MOVED. THE CUSTOMER DID NOT KNOW THE DATE OR WHEN THE ISSUE OCCURRED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16181822 ↗
• MalfunctionJun 10, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR FOR THE ISSUE OF A FAILED LEAK TEST DURING REPROCESSING. THERE IS NO HARM REPORTED TO ANY PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE INSERTION TUBE COATING HAD PEELED OFF. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF INSERTION TUBE COATING HAD PEELED OFF AS OBSERVED DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14659432 ↗
• MalfunctionApr 25, 2022Material Separation; Material Separation

  A USER FACILITY REPORTED TO OLYMPUS THAT THE INSTRUMENT CHANNEL PORT PLASTIC WAS "LIFTING." THE PROBLEM, AS REPORTED TO OLYMPUS, WAS IDENTIFIED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14194315 ↗
• MalfunctionOct 4, 2021Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE BRONCHOVIDEOSCOPE HAD FAILED THE LEAK TEST DURING REPROCESSING, WHICH HAD OCCURRED AFTER AN UNKNOWN DIAGNOSTIC PROCEDURE HAD BEEN COMPLETED. THE PROCEDURE HAD BEEN COMPLETED USING THE SAME DEVICE. THE DEVICE HAD BEEN LEAKING AT THE DISTAL END OF THE INSERTION TUBE. THE DEVICE HAD BEEN INSPECTED PRIOR TO THE PROCEDURE BUT NO ABNORMALITIES WERE OBSERVED AT THE TIME OF THE INSPECTION. THE DEVICE HAD NOT COME IN CONTACT WITH A SHARP OBJECT OR HARD SURFACE. THE DEVICE IS LEAK TESTED AFTER EVERY USE. THE RETURNED DEVICE WAS INSPECTED AND EXCESSIVE PEELING ON THE INSERTION TUBE COATING WAS FOUND. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568652 ↗
• MalfunctionApr 15, 2021Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED FOR THIS EVENT, THE DEVICE HAD SOME PEELING THROUGH THE DISTAL CHANNEL. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670247 ↗
• InjuryMar 31, 2021Contamination; Crack; Contamination; Crack

  IT IS REPORTED 54 DAYS POST BRONCHOSCOPY PROCEDURE FOR THE INDICATION OF CHRONIC COUGH AND ABNORMAL CT 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 11597452 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem

  CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 12-MAR-2021.

  Patient problems: Bacterial Infection; Respiratory Tract Infection

  MAUDE report 11597296 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED 48 DAYS POST BRONCHOSCOPY PROCEDURE FOR THE INDICATION OF CHRONIC COUGH WITH ABNORMAL CT, AND PERSONAL HISTORY OF LUNG CANCER 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 DIED (B)(6) 2021 FROM PRE-EXISTING COMORBIDITIES.

  Patient problems: Bacterial Infection

  MAUDE report 11597214 ↗
• InjuryMar 31, 2021Contamination; Crack; Contamination; Crack

  IT IS REPORTED 48 DAYS POST BRONCHOSCOPY PROCEDURE FOR THE INDICATION OF CHRONIC COUGH WITH ABNORMAL CT, AND PERSONAL HISTORY OF LUNG CANCER 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 DIED 28FEB2021 FROM PRE-EXISTING COMORBIDITIES.

  Patient problems: Respiratory Tract Infection

  MAUDE report 11597196 ↗
• InjuryMar 31, 2021Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem

  IT IS REPORTED 47 DAYS POST BRONCHOSCOPY PROCEDURE FOR THE INDICATION OF CAVITARY LESION OF LUNG, AND PNEUMONIA 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 11596725 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem

  CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 12-MAR-2021.

  Patient problems: Bacterial Infection

  MAUDE report 11596668 ↗