استدعاء جهاز أوليمبوس الطبي بسبب الاحتراق داخل القصبات, USA

United States

Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment during therapeutic procedures within the tracheobronchial tree. The devices were distributed across the United States and internationally.

This corrective action supersedes the 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 Field Corrective Action in 2023, Olympus has conducted additional assessments on the use of bronchoscopes with laser therapy, argon plasma coagulation, and high-frequency cauterization equipment. Through these investigations of clinical conditions, Olympus determined that additional updates to the instructions for use are necessary. Since 2023, Olympus has received reports of four additional incidents involving serious injury, including one from the U.S.

Customers were notified of the instructions for use updates through a September 2025 letter and are asked to ensure all personnel are completely knowledgeable and thoroughly aware of the updates to the instructions for use contained in the customer letter when using the bronchoscopes.

Additional instructions to further reduce the risk of potential combustion associated with the use of laser therapy, argon plasma coagulation, or high-frequency cauterization equipment include specific recommendations: ensuring there is separation of >4cm between the endoscope and the endotracheal tube; oxygen levels of less than 40%; energy output of less than 40 watts; avoiding excessive energy applied to one spot; and the use of suction to evacuate smoke.

There is 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 endobronchial combustion occurs, patients may suffer critical internal burns to the airway or lungs that 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 that may injure or remain unintendedly in the patient and/or may require retrieval or surgical removal.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-issues-voluntary-labeling-update-bronchoscopes-used-laser-therapy-equipment