Skip to content
Recall Observatory FDA recall evidence

Device product

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170

Z-0192-2024

October 12, 2023

Class I

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 93052
Status
Ongoing
Classification
Class I
Quantity
32211 devices
Official record key
device-enforcement:Z-0192-2024

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-1TH190 UDI-DI: 4953170335181; Model BF-H190 UDI-DI: 4953170335174; Model BF-Q170 UDI-DI: 4953170342912 Model BF-Q190 UDI-DI: 4953170335198

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.