Olympus announced today that it made a voluntary corrective action to provide further clarification on the use of certain bronchoscopes.
The company’s global action aims to outline the safe and effective use of its bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment during therapeutic procedures within the tracheobronchial tree.
This corrective action supersedes a previous communication in 2023 addressing adverse event complaints. Those complaints included reports of endobronchial combustion involving therapeutic instruments with Olympus bronchoscopes. That communication included one reported death related to the issue.
Since that action in 2023, the Japanese medtech giant conducted additional assessments on the use of the scopes with laser therapy, argon plasma coagulation and high-frequency cauterization equipment. These investigations led Olympus to determine the need for additional updates to the instructions for use.
Going back to 2023, the company reports four additional incidents involving serious injury, including one in the U.S.
The bronchoscope issue is one of a handful faced by Olympus over the past few years. It also dealt with multiple instances of FDA scrutiny surrounding its devices made in Japan. The agency sent Olympus a warning letter in 2023 related to adultered endoscopes following an inspection of the company’s Tokyo facility. The company received two separate letters at the end of 2022 as well.
CEO Bob White recently explained his plans for the future of Olympus as it works through this scrutiny. Read more here.
Olympus notified customers of the instruction updates in a September 2025 letter. It asked to ensure all personal are made aware of the updates when using the bronchoscopes.
Additional instructions issued by the company aim to further reduce the risk of potential combustion associated with the scopes. Specific recommendations include:
- Ensuring separation of >4cm between the endoscope and the endotracheal tube.
- Keeping oxygen levels at less than 40%.
- Ensuring energy output of less than 40 watts.
- Avoiding excessive energy applied to one spot.
- The use of suction to evacuate smoke.
Olympus says a risk of combustion remains with oxygen supply in excess of 40% and/or the electrode section of the electrosurgical accessory being too close to the distal end of the endoscope.
If endobronchial combustion occurs, patients may suffer critical internal burns to the airway or lungs. This may result in a requirement for additional medical intervention, prolonged procedure, extended hospitalization or ICU care and death. Combustion can also result in damage to or breakage of device components. Those may injure or remain in the patient inadvertently and/or may require retrieval or surgical removal.
Olympus advises users to consult the respective instructions for use for devices that may be used with Olympus bronchoscopes.
