Olympus Corporation of the Americas: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180

Hazard

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

Details from the source

Reason for recall: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope. Distribution: US Nationwide distribution Quantity: 13950 devices Lot/code info: Model BF-1T180 UDI-DI: N/A; Model BF-1TQ180 UDI-DI: N/A; Model BF-P180 UDI-DI: N/A;

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.