Evis Exera Video System and OES - Bronchoscopes

Olympus has received complaints of endobronchial combustion during therapeutic procedures using lasers or argon plasma coagulation with the Olympus bronchoscope. If endobronchial combustion occurs, patients may suffer internal burn in their airway or lungs, respiratory insufficiency, apnea, loss of consciousness, hospitalization or its prolongation, ICU care, or death.

Three (3) adverse event complaints with endobronchial combustion during laser or argon plasma coagulation procedures have occurred, of which one (1) complaint resulted in patient death. In an effort to maximize patient safety and mitigate any potential risk to patient health, Olympus is notifying users of these complaints and the providing the following recommendations related in combination with laser therapy equipment:

- Only Nd:YAG laser or 810 nm diode lasers may be used with Olympus laser compatible bronchoscopes. Olympus has not evaluated any other lasers for compatibility with the indicated bronchoscope models

- Do not perform laser cauterization while supplying oxygen. This may result in combustion during cauterization. This is included in the warnings in the operation manual on laser cauterization with Olympus bronchoscopes.

- Never emit laser radiation before confirming that an appropriate distance between the target and the endoscope's distal end with the tip of the laser probe is in the correct position in the endoscopic image. This is essential to avoid patient injury (burns, bleeding, & perforation) or damage to the device.

Recall start date: June 30, 2023