Device product
Bronchovideoscope BF-1T180
Z-3285-2018
Product summary
- Event
- Event 80925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5810
- Official record key
device-enforcement:Z-3285-2018
Official wording
Reason: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
Code information: all lot codes
Distribution pattern: The products were distributed US nationwide and Canada.
Derived failure modes
-
Unknown
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.