Olympus Provides Label Update Regarding Endobronchial Combustion

Olympus announced a voluntary, global medical device corrective action to clarify safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation, or high-frequency cauterization equipment during therapeutic procedures in the tracheobronchial tree.

This corrective action supersedes previous related communication in 2023 to address adverse event complaints of endobronchial combustion involving therapeutic instruments with Olympus bronchoscopes, which included one death.

Since the 2023 corrective action, the company underwent additional assessment on use of bronchoscopes with laser therapy, argon plasma coagulation, and high-frequency cauterization equipment. Olympus determined further updates to the instructions for use were necessary—since 2024, the company received reports of four additional incidents involving serious injury, including one in the U.S.

The instructions include ensuring there’s a separation of >4 cm between the endoscope and the endotracheal tube and oxygen levels of less than 40%. They also included energy output of less than 40 watts, avoiding excessive energy applied to one spot, and use of suction to evacuate smoke.

There’s a risk of endobronchial combustion if laser therapy, argon plasma coagulation, or high-frequency cauterization is performed while supplying oxygen in excess of 40% and/or the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

If combustion happens, patients can suffer internal burns to the airway or lungs that can require additional medical intervention, prolonged procedure, extended hospitalization or ICU care, or death. Combustion can also cause device component damage or breakage that may injure or remain in the patient and/or may need retrieval or surgical removal.