EVIS EXERA BRONCHOVIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one EVIS EXERA BRONCHOVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 91
- Deaths reported
- 1
- Injuries reported
- 10
- Recalls
- 6
We found 3 models of EVIS EXERA BRONCHOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 91 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2018 and Jan 8, 2026 — classified as 1 death, 10 injuries, 80 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (40 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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 BRONCHOVIDEOSCOPE 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 11, 2025Open, 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-0065-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Sep 25, 2023Open, 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-0327-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Z-2503-2023 · Root cause: Labeling Change Control · names 2 of these models · Recall details · FDA record ↗
- Jul 27, 2023Open, Classified
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Z-2490-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- Jun 8, 2023Open, Classified
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Z-2014-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 8, 2022Open, 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-1047-2022 · Root cause: Other · Recall details · FDA record ↗
Most reported EVIS EXERA BRONCHOVIDEOSCOPE problems
Device problems
- No Display/Image40
- Microbial Contamination of Device12
- Thermal Decomposition of Device9
- Device Reprocessing Problem8
- Material Split, Cut or Torn7
- Peeled/Delaminated6
- Poor Quality Image6
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- Bacterial Infection5
- No Known Impact Or Consequence To Patient5
- No Consequences Or Impact To Patient3
- Chills1
- Death1
- Fever1
EVIS EXERA BRONCHOVIDEOSCOPE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1 death41 reports
- EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 3C160BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls45 reports
- EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 3C160BRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall5 reports
Recent EVIS EXERA BRONCHOVIDEOSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2026Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED A FLICKERING IMAGE DURING ANGULATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005992 ↗MalfunctionJan 8, 2026No Display/Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THERE WAS NO IMAGE ON THE BRONCHOVIDEOSCOPE WHEN PLUGGED INTO THE LIGHT SOURCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003224 ↗MalfunctionDec 28, 2025Break; No Display/Image; Break; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED NO IMAGE DUE TO CRACKED OPTICAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903931 ↗MalfunctionAug 21, 2025Corroded; No Display/Image; Communication or Transmission Problem; Corroded; No Display/Image; Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHO VIDEOSCOPE EXHIBITED CORROSION ON THE CONNECTOR, CONNECTION ISSUES WITH THE ELECTRICAL CONNECTOR, AND NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22866672 ↗MalfunctionAug 7, 2025Poor Quality Image; Poor Quality Image
NO NEW ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22745932 ↗MalfunctionJul 24, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
DURING THE PREVENTIVE INSPECTION, IT WAS FOUND THAT THE SCOPE INTERMITTENTLY DISPLAYS IMAGES. NO HARM REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22585351 ↗MalfunctionJul 22, 2025Overheating of Device; Overheating of Device
IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566403 ↗MalfunctionMay 12, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD IMAGE INTERFERENCE OCCUR WHERE THE BRONCHIAL IMAGE DISAPPEARED AND A BLACK SCREEN WITH ¿WHITE STRIPES¿ APPEARED. THERE WERE NO REPORTS OF PATIENT HARM. THE ISSUE OCCURRED WHILE PERFORMING THE BRONCHOSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22004032 ↗MalfunctionJan 10, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21129997 ↗MalfunctionDec 3, 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 20835620 ↗MalfunctionNov 21, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD INTERMITTENT IMAGE WHILE MANIPULATING THE INSERTION TUBE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20747330 ↗MalfunctionNov 18, 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 20707792 ↗MalfunctionNov 14, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED A BURNED OR MELTED PLASTIC DISTAL END COVER 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 20692024 ↗MalfunctionNov 13, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20678013 ↗MalfunctionNov 12, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT 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 20664261 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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