Olympus Corporation has announced a voluntary global corrective action regarding the use of its bronchoscopes with laser therapy, argon plasma coagulation, and high-frequency cauterization equipment. The company is updating labeling to clarify safe practices for these procedures within the tracheobronchial tree.
This update follows a previous communication from 2023 that addressed adverse events, including one death, linked to endobronchial combustion when using therapeutic instruments with Olympus bronchoscopes. Since then, Olympus has conducted further assessments and identified the need for additional updates to instructions for use. Four more serious injury incidents have been reported since 2023, one of which occurred in the United States.
Customers were notified about these instruction updates through a letter sent in September 2025. They are being asked to ensure all staff are familiar with and follow the new guidance when operating bronchoscopes.
The updated recommendations include maintaining a separation of more than four centimeters between the endoscope and endotracheal tube, keeping oxygen levels below 40%, limiting energy output to under 40 watts, avoiding prolonged application of energy at one spot, and using suction to remove smoke during procedures.
Olympus warns that there is a risk of endobronchial combustion if procedures are performed while supplying oxygen above 40% or if the electrode section is too close to the distal end of the scope. Such incidents can result in critical internal burns requiring extra medical intervention or surgery and may cause device damage or breakage inside patients.
Olympus advises users to review instructions for any devices used alongside their bronchoscopes. Adverse reactions or quality problems can be reported through the FDA's MedWatch program online at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda.
For further information or to report issues with these devices, customers can contact Olympus Technical Assistance Center by phone or email as provided in company communications.
