Olympus OES Bronchofiberscope Models Recalled for Combustion Risk During Laser Procedures
Olympus is recalling OES Bronchofiberscope models due to reports of combustion during laser procedures. This poses a serious burn injury risk to patients.
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 an FDA Class I medical device recall, which mandates a minimum severity score of 4 per the rubric. The hazard—endobronchial combustion during laser procedures—directly poses serious thermal burn injury risk to patients.
Plain-English summary
Olympus Corporation of the Americas is recalling specific models of the OES Bronchofiberscope: the BF-XT40, BF-P60, BF-MP60, and BF-1T60. Approximately 1535 units of these devices have been distributed nationwide in the United States.
The FDA has classified this as a Class I recall due to reports of endobronchial combustion occurring during therapeutic laser procedures when using these bronchofiberscopes. Endobronchial combustion poses a serious risk of thermal burn injury to patients undergoing these procedures.
The recalled product
- Product
- Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Bronchoscopy
- Hazard
- Affected units
- 1,535
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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