Five Olympus Bronchovideoscope Models Recalled for Endobronchial Combustion Risk
Olympus is recalling 15,942 bronchovideoscope units nationwide due to endobronchial combustion risk during cauterization procedures with oxygen supply. The hazard occurs when the electrode of the surgical accessory is positioned too close to the scope's distal end.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class I FDA recall, which carries a minimum severity level of 4 per the rubric. Although no deaths or serious injuries have been reported, the hazard—combustion during a medical procedure—poses a significant risk of serious injury in clinical use.
Plain-English summary
Olympus Corporation of the Americas is recalling 15,942 bronchovideoscopes across five models: BF-1T150, BF-1T60, BF-P150, BF-P60, and XT160. These devices have been distributed nationwide.
The recalled devices present a risk of endobronchial combustion (fire or burning inside the airways) if high-frequency cauterization is performed while oxygen is being supplied through the scope, and the electrode section of the electrosurgical accessory is positioned too close to the endoscope's distal end (tip).
The combustion risk applies specifically to procedures combining oxygen supply and high-frequency cauterization. Healthcare facilities using these bronchovideoscopes should review their procedures and consider alternative approaches or devices for cauterization with oxygen supply.
The recalled product
- 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
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- combustion
- burn-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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
Distributed nationwide across the United States.
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