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Recall Observatory FDA recall evidence

Device product

Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

Z-2016-2023

June 08, 2023

Class I

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92362
Status
Ongoing
Classification
Class I
Quantity
17,609 units
Official record key
device-enforcement:Z-2016-2023

Official wording

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

Code information: All serial numbers BF-P180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 UDI: 04953170339288 BF-Q180** EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 UDI: 04953170339301 BF-Q180-AC* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC UDI: 04953170340086 BF-1T180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 UDI: 04953170339325 BF-1TQ180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 UDI: 04953170339349

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.