EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 (UDI 04953170308215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04953170308215), received between Dec 21, 2023 and Sep 30, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (5 reports).

1 FDA recall record name this device's identifier, 1 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. 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 ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Thermal Decomposition of Device

  The customer reported the Bronchovideoscope had a separate issue. During the initial evaluation of the device it was observed, C-cover had a burn. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947558 ↗
• MalfunctionSep 30, 2026Thermal Decomposition of Device

  The customer reported C-cover burnt during service/maintenance involving an Olympus Bronchovideoscope. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944260 ↗
• MalfunctionSep 18, 2026Erratic or Intermittent Display; No Display/Image

  It was reported by the customer that there was no image on the scope. The issue was found during set up for an unspecified procedure. During the initial evaluation of the device it was observed, that image noise occurs. No harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50826766 ↗
• MalfunctionApr 3, 2026Poor Quality Image

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775689 ↗
• MalfunctionApr 2, 2026Corroded; Poor Quality Image; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED A CHIP ON DISTAL END, C-COVER HAS CORROSION AND THERE WAS A NOISY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24770949 ↗
• MalfunctionMar 24, 2026Degraded; Melted

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED THE CONNECTING TUBE HAD THE COATING PEELING AND THE DISTAL END HAD A BURNED. THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681653 ↗
• MalfunctionMar 9, 2026Degraded; Material Deformation

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED THE COATING OF THE CONNECTING TUBE WAS PEELING AND THE FORCEPS CHANNEL PORT WAS SHAVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546664 ↗
• MalfunctionMar 6, 2026Thermal Decomposition of Device

  IT WAS REPORTED DURING REPROCESSING, THE PLASTIC DISTAL END COVER OF THE BRONCHOVIDEOSCOPE WAS BURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530477 ↗
• MalfunctionSep 12, 2025Decrease in Suction; Positioning Failure; Material Discolored; Misfocusing; Low Test Results; Flare or Flash; Gas/Air Leak; Temperature Problem; Decrease in Suction; Positioning Failure; Material Discolored; Misfocusing; Low Test Results; Flare or Flash; Gas/Air Leak; Temperature Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE HAD A BURN ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23035575 ↗
• MalfunctionAug 22, 2025No Display/Image; No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOVIDEOSCOPE EXHIBITED DUE TO DAMAGE ON THE CCD UNIT, THE IMAGE IS NOT DISPLAYED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877475 ↗
• MalfunctionMay 13, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE EXPERIENCED INTERMITTENT IMAGE LOSS. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011724 ↗
• MalfunctionFeb 22, 2024Thermal Decomposition of Device; Leak/Splash; Thermal Decomposition of Device; Leak/Splash

  IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE HAD A LEAK ON THE BENDING SECTION COVER OR DISTAL SHEATH, AND THE PLASTIC DISTAL END COVER HAD A BURN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758551 ↗
• MalfunctionJan 24, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE REPORTED ISSUE WAS FOUND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18572217 ↗
• MalfunctionDec 21, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE BRONCHOVIDEOSCOPE DISTAL END SCOPE HAD BURNING. THE CUSTOMER SUSPECTED THAT THE BURNING CAME FROM AN ELECTROSURGERY UNIT WHICH WAS USED DURING THE PREVIOUS CASE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377913 ↗