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Recall Observatory FDA recall evidence

Device product

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190

Z-0194-2024

October 12, 2023

Class I

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 93052
Status
Ongoing
Classification
Class I
Quantity
3948 devices
Official record key
device-enforcement:Z-0194-2024

Official wording

Reason: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

Code information: Model BF-P190 UDI-DI: 4953170342110

Distribution pattern: US Nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.