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Recall Observatory FDA recall evidence

Device product

Bronchovideoscope F-1TQ180

Z-3288-2018

August 08, 2018

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 80925
Status
Terminated
Classification
Class II
Quantity
1134
Official record key
device-enforcement:Z-3288-2018

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

    reason.no_named_rule · v1.0.0

    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.