Olympus has initiated a voluntary field corrective action following reports of endobronchial combustion incidents involving bronchoscopes.
The field corrective action — announced Nov. 9 — is taking place after incidents occurred during medical procedures utilizing high-frequency therapy equipment in environments rich in oxygen, according to the company.
The warnings are separate from Olympus’ July field corrective action involving laser-compatible bronchoscopes tied to reports of endobronchial combustion, serious patient injury, and one death.
The new round of bronchoscope warnings came after Olympus received complaints about adverse events, some resulting in serious patient injuries. Endobronchial combustion could result in burns to the airway or lungs, necessitating additional medical intervention, prolonged procedures, extended hospital stays, intensive care, and in some cases, fatalities.
Health providers use the bronchoscope in endoscopic diagnosis and treatment within the airways and the tracheobronchial tree. According to Olympus, it’s still possible to use the devices when following the instructions and warnings outlined in the Olympus Operation Manual.
The company has included 28 models of its BF series endoscopes in this action globally, with 15 models distributed in the U.S.
Olympus said it notified U.S. customers via letter on Oct. 12 about the field corrective action. The company urged healthcare professionals who use its bronchofiberscopes or bronchovideoscopes to familiarize themselves with the full Medical Device Corrective Action. The company stresses the importance of thoroughly knowing the warnings about using compatible high-frequency therapy equipment, such as electrosurgical generators.
The Operation Manuals for Olympus bronchoscopes caution against performing high-frequency cauterization while supplying oxygen, which could lead to combustion. To prevent patient injuries like burns, bleeding, or perforation, and to avoid damaging the device, Olympus advises ensuring that the electrode section of the electrosurgical accessory is kept at a safe distance from the endoscope’s distal end.