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Recall Observatory FDA recall evidence

Device product

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160

Z-0189-2024

October 12, 2023

Class I

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 93052
Status
Ongoing
Classification
Class I
Quantity
15942 devices
Official record key
device-enforcement:Z-0189-2024

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-1T150 UDI-DI: 4953170308185; Model BF-1T60 UDI-DI: 4953170339264; Model BF-P150 UDI-DI: N/A; Model BF-P60 UDI-DI: 4953170339196; Model BF-XT160 UDI-DI: N/A

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.