Olympus Bronchovideoscopes Recalled for Endobronchial Combustion Risk
Olympus is recalling bronchovideoscopes nationwide due to a risk of combustion inside the bronchial passages during high-frequency cauterization if oxygen is supplied or the electrode is positioned too close to the scope's tip.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall; per the severity rubric rule, Class I recalls never score below 4. The risk of endobronchial combustion during cauterization procedures poses serious potential for patient harm. No deaths or reported injuries are documented in the source text.
Plain-English summary
Olympus Corporation of the Americas is recalling four models of EVIS EXERA III bronchovideoscopes and the BRONCHOVIDEOSCOPE OLYMPUS BF-Q170. The affected models are BF-1TH190, BF-H190, BF-Q190, and BF-Q170, with a total of 32,211 devices recalled.
The risk occurs when high-frequency cauterization is performed while oxygen is supplied or when the electrode section of an electrosurgical accessory is positioned too close to the distal end of the bronchovideoscope. Under these conditions, endobronchial combustion can occur, potentially resulting in serious harm to the patient.
These bronchovideoscopes were distributed nationwide throughout the United States. Healthcare providers and facilities using these devices should be aware of this recall and the associated combustion risk.
The recalled product
- Product
- EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 32,211
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 (3)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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