BRONCHOFIBERSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one BRONCHOFIBERSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 210
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls
- 4
We found 4 models of BRONCHOFIBERSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 210 adverse event reports in the FDA's MAUDE database, received between Mar 12, 2019 and Sep 29, 2026 — classified as 1 death, 8 injuries, 201 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (41 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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
BRONCHOFIBERSCOPE 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-0064-2026 · Root cause: Device Design · Recall details · FDA record ↗
- 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-0059-2026 · Root cause: Device Design · 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 · names 4 of these models · Recall details · FDA record ↗
- Jun 8, 2023Open, Classified
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Z-2012-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported BRONCHOFIBERSCOPE problems
Device problems
- Material Deformation41
- Failure to Clean Adequately30
- Break21
- Peeled/Delaminated21
- Material Split, Cut or Torn19
- Scratched Material19
- Corroded16
- Microbial Contamination of Device11
Patient problems
- No Clinical Signs, Symptoms or Conditions197
- Pneumothorax4
- No Consequences Or Impact To Patient3
- Unspecified Infection3
- Hemorrhage/Blood Loss/Bleeding2
- Bronchospasm1
- Death1
- Hypoxia1
BRONCHOFIBERSCOPE models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BRONCHOFIBERSCOPE BF-TE2BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls113 reports
- BRONCHOFIBERSCOPE BF-PE2BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls85 reports
- BRONCHOFIBERSCOPE BF-TE2BRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall1 death8 reports
- BRONCHOFIBERSCOPE BF-PE2BRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall4 reports
Recent BRONCHOFIBERSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Deformation; Failure to Clean Adequately
The customer returned the Bronchofiberscope to the service center for a separate issue. During the device analysis, the Olympus Service Repair Technician indicated that the Connecting Tube was sticky and the Forceps Channel Port was shaved. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932277 ↗MalfunctionSep 28, 2026Corroded
The customer returned the Bronchofibervideoscope for a separate issue. During the initial evaluation of the returned device, a corroded forceps channel port was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917550 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903034 ↗MalfunctionSep 22, 2026Corroded
The customer returned the bronchofiberscope to the service center for a separate issue. During the device analysis, it was indicated that corrosion on the light guide cover glass unit was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856744 ↗MalfunctionSep 22, 2026Decrease in Suction; Dent in Material
The customer returned the Bronchofiberscope 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 Suction volume does not meet the standard value and the forceps channel port has a dent. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849566 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831119 ↗MalfunctionSep 18, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828727 ↗MalfunctionSep 11, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734740 ↗MalfunctionSep 8, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672702 ↗MalfunctionSep 2, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573100 ↗MalfunctionSep 1, 2026Dent in Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543923 ↗MalfunctionSep 1, 2026Dent in Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50540027 ↗MalfunctionAug 31, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50521681 ↗MalfunctionAug 20, 2026Corroded; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356657 ↗MalfunctionAug 18, 2026Material Deformation
The customer returned the Bronchofiberscope for a separate issue. During the device evaluation it was noted that the insertion tube port was dented. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50301406 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page