EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,257
- Deaths reported
- 4
- Injuries reported
- 107
- Recalls
- 2
We found 8 models of EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 1,257 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2018 and Sep 29, 2026 — classified as 4 deaths, 107 injuries, 1,146 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (399 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-0328-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 27, 2023Class IIOpen, Classified
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Z-2494-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE problems
Device problems
- No Display/Image399
- Detachment of Device or Device Component182
- Failure to Clean Adequately96
- Break93
- Device Reprocessing Problem90
- Poor Quality Image71
- Microbial Contamination of Device68
- Material Fragmentation36
Patient problems
- No Clinical Signs, Symptoms or Conditions1,100
- No Patient Involvement44
- Fungal Infection27
- Bacterial Infection22
- No Consequences Or Impact To Patient15
- No Known Impact Or Consequence To Patient11
- Foreign Body In Patient9
- Respiratory Tract Infection9
EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FUltrasound bronchoscope2 recalls4 deaths1,088 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FSystem, imaging, pulsed doppler, ultrasonic64 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FUltrasound bronchoscope35 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FSystem, imaging, pulsed doppler, ultrasonic35 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FUltrasound bronchoscope18 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FUltrasound bronchoscope8 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FTransducer, ultrasonic, diagnostic5 reports
- EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180FUltrasound bronchoscope4 reports
Recent EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938787 ↗MalfunctionSep 29, 2026Device Reprocessing Problem
The customer reported the device was contaminated after use during reprocessing involving an Olympus Ultrasonic Bronchofibervideoscope. There was no patient injury reported. Despite good faith attempts additional information was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933474 ↗MalfunctionSep 28, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926395 ↗MalfunctionSep 28, 2026Crack
The customer returned the ultrasonic bronchofibervideoscope to the service center for a separate issue. During the device analysis, it was indicated that a chip at the distal end pink rubber was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921629 ↗MalfunctionSep 28, 2026No Display/Image; Failure to Clean Adequately
The customer reported blackish gray discharge during reprocessing involving an Olympus ultrasonic bronchofibervideoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920778 ↗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 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, 2026Erratic or Intermittent Display
The customer returned the Ultrasonic Bronchofibervideoscope for a separate issue. During the initial evaluation of the returned device, an intermittent-flickering image observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887587 ↗MalfunctionSep 24, 2026Break; Device Reprocessing Problem; Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876627 ↗MalfunctionSep 23, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873547 ↗MalfunctionSep 23, 2026Degraded
The customer returned the BRONCHOFIBERVIDEOSCOPE to the service center for evaluation related to a separate issue. During testing, it was identified that the distal end channel outlet was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870250 ↗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 22, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858842 ↗MalfunctionSep 22, 2026Crack; Sharp Edges
The customer returned the Bronchofibervideoscope to the service center for a separate issue. During the device analysis, the Service Repair Technician indicates that a reportable malfunction was found. It was determined that the distal end had cuts at the channel opening pink rubber had chips. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854030 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page