Device product
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
Z-2014-2023
Product summary
- Event
- Event 92362
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 284 units
- Official record key
device-enforcement:Z-2014-2023
Official wording
Reason: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Code information: All serial numbers BF-XT160* EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 UDI: 04953170340147
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.