FDA-Device2023-07-26Class I

Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2

Olympus Corporation of the Americas
Hazard

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

Sold states
US Nationwide Distribution.
Affected count
4 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2012-2023

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