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Recall Observatory FDA recall evidence

Device product

Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150

Z-2013-2023

June 08, 2023

Class I

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92362
Status
Ongoing
Classification
Class I
Quantity
9 units
Official record key
device-enforcement:Z-2013-2023

Official wording

Reason: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Code information: All serial numbers BF-P150* BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 UDI: 04953170288876 BF-1T150 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 UDI: 04953170288968

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.