EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F (UDI 04953170356353)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 bronchoscope is a flexible endoscope with an ultrasonic probe used to look inside the lungs and airways. The 29 reports mostly describe problems found during inspection or cleaning — parts breaking, corrosion on the connector, cover adhesive coming loose, and bits of material coming out of the scope's tip — with no patient involvement described. No deaths or injuries 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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04953170356353), received between Aug 7, 2020 and Sep 25, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Corroded” (6 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
- Corroded6
- Failure to Clean Adequately6
- Break5
- Defective Device2
- Detachment of Device or Device Component2
- Device Reprocessing Problem2
- Fluid/Blood Leak2
- No Display/Image2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Patient Involvement7
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Dent in Material
The customer returned the Ultrasonic Bronchofibervideoscope, which is an Olympus asset with no reported complaint. During the initial evaluation of the returned device, a dent on the forceps channel port was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902584 ↗MalfunctionSep 25, 2026Corroded
The customer returned the ultrasonic broncho fiber videoscope to the service center for a separate issue. During the device analysis, it was indicated that a corroded balloon water delivery and suction ports was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900067 ↗MalfunctionSep 24, 2026Break; Device Reprocessing Problem; Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876627 ↗MalfunctionSep 23, 2026Corroded
The customer returned the ultrasonic bronchofibervideoscope to the service center for a separate issue. During the device analysis, t was indicated that corrosion on the balloon port was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869716 ↗MalfunctionSep 17, 2026Fracture
The customer returned the videoscope to the service center for evaluation related to a separate issue. During the evaluation, a reportable malfunction was identified: the acoustic lens was chipped. As a result, the affected component required replacement. There was no patient involvement associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806600 ↗MalfunctionSep 10, 2026Material Fragmentation; Peeled/Delaminated; Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721837 ↗MalfunctionMay 12, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE HAD A CLOG IN THE BALLOON WATER TUBE AND FOREIGN OBJECTS EXITED FROM THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150328 ↗MalfunctionApr 24, 2026Corroded
DURING THE DEVICE EVALUATION, CORROSION WAS FOUND ON THE ELECTRICAL CONNECTOR OF THE BRONCHO FIBER VIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24989722 ↗MalfunctionApr 20, 2026Loss of or Failure to Bond; Detachment 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 24933684 ↗MalfunctionApr 20, 2026Residue After Decontamination
IT WAS OBSERVED 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 24925659 ↗MalfunctionApr 10, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED FOREIGN MATERIAL COME OUT OF DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844270 ↗MalfunctionMar 30, 2026Contamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE HAD FOREIGN OBJECTS COMING OUT OF THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728188 ↗MalfunctionFeb 23, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED THE ACOUSTIC LENS HAD A CHIP (DAMAGE LEVEL; REACH TO THE GLUE-LAYER). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24423709 ↗MalfunctionFeb 11, 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 24312442 ↗MalfunctionFeb 10, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED DUST/DIRT ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308248 ↗MalfunctionNov 5, 2025Loose or Intermittent Connection; Unstable; Loose or Intermittent Connection; Unstable
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477396 ↗MalfunctionOct 28, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION OF THE BRONCHOFIBERVIDEOSCOPE, THE IMAGE GUIDE (IG) TUBE WAS STICKY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404540 ↗MalfunctionAug 28, 2025Material Deformation; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FORCEPS CHANNEL PORT OF THE BRONCHOFIBERVIDEOSCOPE WAS SHAVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912038 ↗MalfunctionAug 8, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE BRONCHOFIBERVIDEOSCOPE EXHIBITED DEGRADATION OF THE 3D IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22756412 ↗MalfunctionAug 4, 2025Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED, DEFORMATION OF BENDING TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22710283 ↗MalfunctionJul 23, 2025Corroded; Failure to Clean Adequately; Corroded; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED A CLOGGED BALLOON WATER TUBE AND FOREIGN MATERIAL COMING OUT OF THE DISTAL END. IN ADDITION, THE ELECTRICAL CONNECTOR EXHIBITED CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22584159 ↗MalfunctionApr 18, 2025Corroded; Corroded
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE BRONCHOFIBERVIDEOSCOPE EXHIBITED A CORRODED ELECTRICAL CONTACT ON THE ULTRASOUND CONNECTOR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. THE REPORT CAPTURES THE OBSERVED MADE BY OLYMPUS DURING THE SAMPLE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21866061 ↗MalfunctionFeb 7, 2025Material Separation; Material Separation
THE ISSUE WAS OBSERVED DURING PREPARATION FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21337860 ↗MalfunctionJan 23, 2024Microbial Contamination of Device; Microbial Contamination of Device
THE CUSTOMER REPORTED TO OLYMPUS, THAT DURING SCOPE CULTURE TEST, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE TESTED POSITIVE ON (B)(6) 2023, FOR 10-25 COLONY FORMING UNITS (CFUS) OF GRAM POSITIVE COCCI AND GRAM NEGATIVE BACILLI, IT WAS NOT SPECIFIED WHICH CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18566936 ↗MalfunctionSep 28, 2022Break; Break
AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING REPROCESSING THE DEVICE DISTAL TIP BROKE OFF. THERE IS NO PATIENT INVOLVEMENT AND NO REPORTED HARM TO ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15496394 ↗
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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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