Olympus Bronchovideoscope Recalled for Fire Risk During Cauterization
Olympus Corporation recalls 13,950 EVIS EXERA II bronchovideoscopes due to risk of endobronchial combustion when high-frequency cauterization is performed with oxygen supplied while the electrode is positioned too close to the endoscope.
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: This device has been classified as FDA Class I, which mandates a minimum severity score of 4. The hazard of endobronchial combustion during electrosurgical procedures presents a serious risk of life-threatening injury. No deaths or illnesses have been reported in the source material.
Plain-English summary
Olympus Corporation of the Americas is recalling approximately 13,950 EVIS EXERA II Bronchovideoscope devices (Model Numbers BF-1T180, BF-1TQ180, and BF-P180). The devices are distributed nationwide in the United States.
The recall addresses a risk of endobronchial combustion—fire or explosion within the patient's airway—that can occur during high-frequency cauterization procedures. This risk is highest when oxygen is being supplied and the electrode section of the electrosurgical accessory is positioned too close to the distal end of the endoscope.
Healthcare providers using these devices should contact Olympus Corporation of the Americas for information on replacement, repair, or alternative procedures. This is a Class I recall issued by the FDA, indicating a serious hazard.
The recalled product
- Product
- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 13,950
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-1T180 UDI-DI: N/A
- Model BF-1TQ180 UDI-DI: N/A
- Model BF-P180 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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