Device product
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Z-2012-2023
Product summary
- Event
- Event 92362
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2012-2023
Official wording
Reason: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Code information: All serial numbers BF-PE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 UDI: 04953170339974 BF-TE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 UDI: 04953170339998
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.