EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F (UDI 04953170243233)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus EVIS EXERA II ultrasonic bronchoscope is a flexible scope used to look inside the lungs and airways, with built-in ultrasound. Reports mostly describe cleaning and reprocessing problems, a blank or missing image, germs found in the device, and damage such as chipped lenses, peeling adhesive and a shaved forceps channel. There are 62 reports, 18 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 64
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 04953170243233), received between Jun 1, 2020 and Sep 28, 2026 — classified as 18 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (14 reports).
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.
Reports received per month
Most reported problems
Device problems
- Failure to Clean Adequately14
- Microbial Contamination of Device12
- No Display/Image12
- Device Reprocessing Problem9
- Detachment of Device or Device Component7
- Break3
- Material Fragmentation3
- Loss of or Failure to Bond2
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- Respiratory Tract Infection8
- Fungal Infection6
- Dyspnea3
- Bacterial Infection2
- Cough2
- Cancer1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Fragmentation
The customer returned the Ultrasonic Bronchofibervideoscope to the service center for a separate issue. During the device analysis, the Olympus Service Repair Technician indicated that the Acoustic Lens had a chip. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914504 ↗MalfunctionSep 14, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765497 ↗MalfunctionAug 26, 2026Poor Quality Image; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50454416 ↗MalfunctionMay 8, 2026Material Deformation
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED A SHAVED FORCEPS CHANNEL PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128590 ↗MalfunctionMay 7, 2026Loss of or Failure to Bond; Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED THAT THE DISTAL END HAS A CHIP AND THERE IS A CHIP IN ADHESIVE AREA BETWEEN ACOUSTIC LENS AND THE ULTRASOUND PROBE, THE ADHESIVE ON THE BENDING SECTION COVER (A-RUBBER) IS DETACHED AND THE ADHESIVE ON THE BENDING SECTION COVER (A-RUBBER) HAS A CHIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116621 ↗MalfunctionApr 20, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED THAT THE ADHESIVE ON THE BENDING SECTION COVER (A-RUBBER) IS DETACHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24933579 ↗MalfunctionApr 15, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED FOREIGN OBJECTS COMING OUT OF THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24888422 ↗MalfunctionApr 10, 2026Loss of or Failure to Bond
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE ACOUSTIC LENS ADHESIVE HAD A CHIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839377 ↗MalfunctionApr 9, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830326 ↗MalfunctionApr 7, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED A CHIPPED LIGHT GUIDE LENS THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802713 ↗InjuryMar 10, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE BALLOON FELL OFF FROM THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE AND WAS LEFT BEHIND IN THE PATIENT'S AIRWAY DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND. THE PROCEDURE WAS STOPPED AND THE PROVIDER SWITCHED TO A REGULAR BRONCHOSCOPE TO RETRIEVE THE BALLOON FROM THE LEFT MAIN STEM BRONCHUS USING SUCTION. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE WITH A DELAY OF LESS THAN 30 MINUTES. THERE WERE NO REPORTS OF FURTHER PATIENT HARM. THIS REPORT IS 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557461 ↗InjuryFeb 20, 2026Detachment of Device or Device Component
REPORT 2 OF 2. IT WAS REPORTED THAT DURING AN EBUS (ENDOBRONCHIAL ULTRASOUND) THE BALLOON FELL OFF THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE INTO THE PATIENT¿S LUNG. THE PHYSICIAN NOTICED IT WAS NOT ON THE SCOPE WHEN HE EXITED THE ET TUBE (ENDOTRACHEAL TUBE). THE BALLOON WAS SUCTIONED TO THE TIP OF THE SCOPE, RETRIEVED THROUGH THE ET TUBE AND THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402777 ↗MalfunctionFeb 17, 2026Collapse; Residue After Decontamination
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED DAMAGE TO THE CHANNEL TUBE AND FOREIGN MATERIAL COMING FROM DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366614 ↗MalfunctionDec 26, 2025Break; No Display/Image; Detachment of Device or Device Component; Environmental Particulates; Failure to Clean Adequately; Break; No Display/Image; Detachment of Device or Device Component; Environmental Particulates; Failure to Clean Adequately
IT WAS REPORTED THAT THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE WAS NOT POSSIBLE TO PERFORM THE LEAK TEST, AS THE EQUIPMENT DID NOT HAVE RUBBER AT THE TIME OF EVALUATION AND INSPECTION. THE INSPECTION FOUND A LOOSE DISTAL COVER, ASSOCIATED WITH POSSIBLE IMPROPER HANDLING DURING USE OF THE EQUIPMENT, AND THE IMAGE TEST WITH SIGNIFICANT LOSS OF VISION, CAUSED BY BROKEN FIBERS, A CONDITION CONSISTENT WITH PREVIOUS MOISTURE INGRESS, WHICH COULD HAVE LED TO INTERNAL CRYSTALLIZATION AND SUBSEQUENT DEGRADATION OF THE FIBERS. AND THE DISTAL COVER WITH DIRT PRESENT, POSSIBLY DUE TO AN IMPROPER REPROCESSING PROCESS. THE ISSUE OCCURRED AT PREPARATION FOR USE AND BEFORE THE PATIENT WAS IN THE ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23898133 ↗MalfunctionDec 9, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759312 ↗MalfunctionAug 11, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHO FIBER VIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22774052 ↗MalfunctionJan 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE, THE BALLOON CAME OFF ON THE GAUZE DURING LUBRICATION OF THE SCOPE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS AN UNKNOWN DELAY WITH NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21185147 ↗MalfunctionDec 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A RED SUBSTANCE WAS DISCOVERED IN THE WORKING CHANNEL WITH BORESCOPE PRIOR TO MANUAL CLEANING DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20904067 ↗MalfunctionDec 5, 2024Break; Break
IT WAS REPORTED THAT DURING REPROCESSING OF THE SUBJECT DEVICE, A LITTLE PIECE OF TAN COLORED PLASTIC BROKE OFF FROM THE DISTAL TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20855835 ↗MalfunctionNov 1, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20591904 ↗MalfunctionOct 16, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE BRONCHOFIBERVIDEOSCOPE HAD A POOR CONNECTION IMAGE PROBLEM. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20462603 ↗MalfunctionAug 12, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19968644 ↗MalfunctionAug 5, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED FOREIGN OBJECTS AT THE BALLOON CHANNEL OPENING AT DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19905696 ↗MalfunctionJul 11, 2024No Display/Image; No Display/Image
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOFIBER VIDEOSCOPE¿S IMAGE WAS NOT DISPLAYED DUE TO A DAMAGED CHARGED COUPLED DEVICE UNIT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19721900 ↗MalfunctionJun 18, 2024Device Reprocessing Problem; Device Reprocessing Problem
OLYMPUS WAS INFORMED THAT DURING AN ONSITE VISIT, THE USER FACILITY STAFF USED A 10ML SYRINGE INSTEAD OF A 30 ML SYRINGE TO REPROCESS A BRONCHOFIBERVIDEOSCOPE. NO PATIENT INFECTIONS OR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560720 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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