EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 (UDI 04953170339349)Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 04953170339349), received between Jul 13, 2018 and Apr 16, 2026 — classified as 4 injuries, 60 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (19 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-0051-2026 · 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-2493-2023 · 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 ↗

4. 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-1049-2022 · Root cause: Other · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Display or Visual Feedback Problem; Detachment of Device or Device Component

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD IMAGE LOSS WHEN THE SCOPE WAS ROTATED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905330 ↗
• MalfunctionJan 8, 2026Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED CORROSION ON THE BENDING SECTION COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006148 ↗
• MalfunctionJan 7, 2026Material Separation; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE HAD THE LIGHT GUIDE LENS DETACHED SHOWING ON THE OUTSIDE OF BENDING SECTION AND C-COVER/BENDING SECTION COVER MISSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23998918 ↗
• MalfunctionDec 15, 2025Poor Quality Image; Poor Quality Image

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800125 ↗
• MalfunctionAug 11, 2025Poor Quality Image; Failure to Clean Adequately; Poor Quality Image; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED DIRT ON THE CHARGED COUPLED DEVICE (CCD) LENS CONTRIBUTING TO A POOR QUALITY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772688 ↗
• MalfunctionJul 15, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE WAS NOT PRODUCING AN IMAGE. WHEN PLUGGED IN, THE SCREEN IS JUST BLACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516278 ↗
• MalfunctionNov 22, 2024No Display/Image; No Display/Image

  IT WAS REPORTED, DURING SET UP/INSPECTION FOR USE. THAT THE SUBJECT DEVICE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20763846 ↗
• MalfunctionNov 14, 2024Poor Quality Image; Poor Quality Image

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED A GRAINY IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684715 ↗
• MalfunctionNov 12, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHO VIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNED/MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668750 ↗
• MalfunctionNov 8, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNT/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 20639972 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHO VIDEOSCOPE PLASTIC DISTAL END COVER MELTED OR BURNED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636699 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  DURING THE DEVICE EVALUATION, THE BRONCHO VIDEOSCOPE'S PLASTIC DISTAL END COVER WAS 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 20635781 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS 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 20635641 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS 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 20635346 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS 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 20635054 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE PLASTIC DISTAL END COVER MELTED OR BURNED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20634748 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE PLASTIC DISTAL END COVER MELTED OR BURNED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631744 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE PLASTIC DISTAL END COVER MELTED OR BURNED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631480 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE PLASTIC DISTAL END COVER MELTED OR BURNED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631434 ↗
• MalfunctionNov 4, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNED/MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598945 ↗
• MalfunctionOct 28, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED THE PLASTIC DISTAL END COVER WAS BURNT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552980 ↗
• MalfunctionOct 22, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20503732 ↗
• MalfunctionOct 2, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE HAD NO CONNECTION TO THE VIDEO PATH. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351018 ↗
• MalfunctionMay 28, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE DID NOT PRESENT AN IMAGE. THE ISSUE OCCURRED DURING PREPARATION FOR USE INTENDED FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402963 ↗
• MalfunctionApr 23, 2024No Display/Image; No Display/Image

  IT WAS REPORTED, THE BRONCHOVIDEOSCOPE HAD AN IMAGE DISAPPEAR WHEN THE CABLE BETWEEN THE LIGHT SOURCE AND THE MANEUVER/CONTROL BODY WERE MOVED. THE ISSUE OCCURRED DURING PROCEDURE FOR AN UNSPECIFIED PROCEDURE. THE SCOPE WAS REPLACED DURING THE PROCEDURE. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165343 ↗