Olympus Bronchoscope Recall: Risk of Combustion During Laser Procedures
Olympus is recalling 9 bronchoscopes (Models BF-P150 and BF-1T150) due to complaints of endobronchial combustion during therapeutic laser procedures. The defect could cause fire and serious burn injuries.
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 is an FDA Class I medical device recall, which establishes a minimum severity score of 4. The hazard—endobronchial combustion during laser procedures—presents substantial risk of serious burn injury to patients, meeting the criteria for Severe classification.
Plain-English summary
Olympus Corporation of the Americas is recalling 9 Olympus BRONCHOVIDEOSCOPE units (Model Numbers BF-P150 and BF-1T150) distributed nationwide in the United States.
The recall is due to complaints of endobronchial combustion occurring during therapeutic laser procedures performed with the bronchoscope. Endobronchial combustion refers to an unintended fire occurring within the patient's bronchial passages during the laser treatment.
Patients undergoing bronchoscopy with laser therapy using these devices are at risk of serious burn injury. Hospitals and medical facilities that have these models should immediately cease use and contact Olympus Corporation of the Americas for instructions on return or replacement.
The recalled product
- Product
- Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 9
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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