EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 3C160 (UDI 04953170340031)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 04953170340031), received between Jan 14, 2022 and Jan 8, 2026 — classified as 3 injuries, 42 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (26 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 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0327-2024 · Root cause: Under Investigation by firm · 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-2503-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

3. Mar 8, 2022Class IIOpen, Classified

   Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

   Z-1047-2022 · Root cause: Other · 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.

• MalfunctionJan 8, 2026Erratic or Intermittent Display

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005992 ↗
• MalfunctionDec 28, 2025Break; No Display/Image; Break; No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED NO IMAGE DUE TO CRACKED OPTICAL LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23903931 ↗
• MalfunctionAug 21, 2025Corroded; No Display/Image; Communication or Transmission Problem; Corroded; No Display/Image; Communication or Transmission Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHO VIDEOSCOPE EXHIBITED CORROSION ON THE CONNECTOR, CONNECTION ISSUES WITH THE ELECTRICAL CONNECTOR, AND NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866672 ↗
• MalfunctionJan 10, 2025No Display/Image; No Display/Image

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129997 ↗
• MalfunctionNov 21, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD INTERMITTENT IMAGE WHILE MANIPULATING THE INSERTION TUBE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747330 ↗
• MalfunctionNov 13, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678013 ↗
• MalfunctionSep 18, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252948 ↗
• MalfunctionAug 23, 2024No Display/Image; No Display/Image

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED NO IMAGE ON THE MONITOR DUE TO DAMAGE ON THE CHARGED COUPLED DEVICE UNIT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055155 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE EVIS EXERA BRONCHOVIDEOSCOPE EXHIBITED DAMAGED TO THE INSERTION TUBE. THE COATING PEELED OFF THE INSERTION SECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805249 ↗
• MalfunctionJul 22, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793197 ↗
• MalfunctionJul 16, 2024No Display/Image; No Display/Image

  IT WAS REPORTED, THAT THE BRONCHOVIDEOSCOPE HAD COMPROMISED IMAGE. THERE WAS NO IMAGE, JUST BLURRY COLORS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757783 ↗
• InjuryJul 1, 2024Contamination; Detachment of Device or Device Component; Contamination; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE (IN A PEDIATRIC MALE PATIENT) BLACK PARTICLES/DEBRIS WERE NOTED IN THE AIRWAY AT THE BEGINNING OF THE PROCEDURE THAT LOOKED LIKE A PIECE OF BLACK PLASTIC. IN AN ATTEMPT TO PERFORM A FOREIGN BODY PROCEDURE, THE SCOPE WAS REMOVED FROM THE AIRWAY, INSPECTED FOR ANY DEFECTS AND NO OBVIOUS DEFECTS WERE NOTED ON OUTSIDE OF THE SCOPE. ONCE THE SCOPE WAS REINSERTED THE BLACK MATERIAL WAS NO LONGER VISIBLE IN THE AIRWAY. THE PROCEDURE WAS PROLONGED BY HOURS ALONG WITH ANESTHESIA. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED BUT PROCEDURE EXTENDED FOR HOURS. THE CONDITION OF THE PATIENT AND THE PROCEDURAL OUTCOME WERE NOT IMPACTED BY THE ISSUE. THE SCOPE WAS INSPECTED PRIOR TO USE AND AGAIN AFTER THE BLACK ITEM WAS SEEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643974 ↗
• InjuryJul 1, 2024Contamination; Detachment of Device or Device Component; Contamination; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE (IN A PEDIATRIC MALE PATIENT) BLACK PARTICLES/DEBRIS WERE NOTED IN THE AIRWAY AT THE BEGINNING OF THE PROCEDURE THAT LOOKED LIKE A PIECE OF BLACK PLASTIC. IN AN ATTEMPT TO PERFORM A FOREIGN BODY PROCEDURE, THE SCOPE WAS REMOVED FROM THE AIRWAY, INSPECTED FOR ANY DEFECTS AND NO OBVIOUS DEFECTS WERE NOTED ON OUTSIDE OF THE SCOPE. ONCE THE SCOPE WAS REINSERTED THE BLACK MATERIAL WAS NO LONGER VISIBLE IN THE AIRWAY. THE PROCEDURE WAS PROLONGED BY HOURS ALONG WITH ANESTHESIA. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED BUT PROCEDURE EXTENDED FOR HOURS. THE CONDITION OF THE PATIENT AND THE PROCEDURAL OUTCOME WERE NOT IMPACTED BY THE ISSUE. THE SCOPE WAS INSPECTED PRIOR TO USE AND AGAIN AFTER THE BLACK ITEM WAS SEEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643965 ↗
• MalfunctionJun 18, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS NO IMAGE WHEN USING THE BRONCHOVIDEOSCOPE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564110 ↗
• MalfunctionJun 3, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SCREEN ON THE BRONCHOVIDEOSCOPE BLACKED OUT AND DISPLAYED NO IMAGE. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19450179 ↗
• MalfunctionApr 10, 2024No Display/Image; No Display/Image

  IT WAS REPORTED, THAT THE IMAGE ISSUE WAS OBSERVED, DURING REPROCESSING. ALTHOUGH, THERE WAS REPORT OF A PROCEDURAL DELAY, DUE TO THE ISSUE. THE DURATION OF THE DELAY WAS UNSPECIFIED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076931 ↗
• MalfunctionFeb 7, 2024No Display/Image; No Display/Image

  IT WAS REPORTED, THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING REPROCESSING OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658376 ↗
• MalfunctionJan 16, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE BRONCHOVIDEOSCOPE DID NOT PROVIDE VIDEO OUTPUT. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. IT WAS NOTED THAT THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522923 ↗
• MalfunctionJan 10, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXCERA BRONCHOVIDEOSCOPE HAD NO IMAGE ON THE SCREEN. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486841 ↗
• MalfunctionDec 20, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BRONCHOVIDEOSCOPE HAD AN IMAGE PROBLEM WITH POOR OPTICS AND FAILED THE LEAK TEST. THE EVENT WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361615 ↗
• MalfunctionDec 11, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS, THE BRONCHOVIDEOSCOPE HAD PARTS FALLING OFF FROM THE DISTAL END INCLUDING THE BENDING SECTION COVER TIP FALLING OFF. THE ISSUE WAS FOUND AT THE END OF AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307902 ↗
• MalfunctionNov 8, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE DID NOT DISPLAY AN IMAGE. IT IS UNCLEAR WHEN THE EVENT OCCURRED, BUT THE CUSTOMER NOTED THAT IT WAS MOST LIKELY DURING REPROCESSING. THERE WAS NO PROCEDURE PERFORMED AND NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096953 ↗
• MalfunctionSep 26, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT DURING PREPARATION FOR USE, WHEN THE EVIS EXERA BRONCHO-VIDEOSCOPE WAS PLUGGED IN, THE IMAGE COULD NOT BE SEEN. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822239 ↗
• MalfunctionSep 1, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA BRONCHOVIDEOSCOPE HAD NO IMAGE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE, THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669679 ↗
• MalfunctionAug 31, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA BRONCHOVIDEOSCOPE HAD A NO IMAGE PROBLEM. THE ISSUE WAS FOUND DURING REPROCESSING INSPECTION. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17667401 ↗