Olympus Bronchovideoscope Recall for Combustion Risk with Electrosurgery
Olympus is recalling 1,154 EVIS EXERA II bronchovideoscope units due to risk of endobronchial combustion during high-frequency electrosurgical procedures when oxygen is supplied and electrode placement is inappropriate.
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 recall with serious hazard potential (endobronchial combustion during endoscopic procedure). Agency classification ensures minimum severity score of 4.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,154 EVIS EXERA II BRONCHOVIDEOSCOPE units (Model BF-Q180-AC) distributed nationwide in the United States.
The recall addresses a risk of endobronchial combustion during high-frequency cauterization procedures when oxygen is supplied to the patient and the electrode section of the electrosurgical accessory is positioned too close to the distal end of the endoscope.
This recall affects healthcare facilities and medical professionals who use this bronchovideoscope model in bronchoscopic procedures.
The recalled product
- Product
- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 1,154
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 (1)
- Model BF-Q180-AC UDI-DI: N/A
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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