Olympus has issued updated corrective action related to the 2023 recall of more than 17,600 bronchoscopes that included flexible, fiber-optic systems and video-camera-equipped devices used to observe a patient’s airway and lungs.
The latest corrective action supersedes the one issued in 2023 that addressed problems with endobronchial combustion of the product that included one death, the company said in an Oct. 31 press release.
Among the new guidelines, users are required to ensure a separation of greater than four centimeters between the endoscope and the endotracheal tube, oxygen levels should not exceed levels of 40%, energy levels should be no higher than 40 watts, and suction should be used to evacuate any smoke.
“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,” the company said.
Such a combustion can also damage or break device components that may injure or remain unintentionally in the patient and require retrieval or surgical removal, it added.
In October 2023, the company issued an alert that there were four reports of combustion occurring within a patient’s lungs when its bronchoscope was used alongside high-frequency energy equipment during a cauterization procedure—sparking a fire in a high-oxygen environment.
Although those cases were related to its Evis Exera III bronchovideoscope, Olympus noted at the time there were 28 endoscope models in the BF series that can be used in combination with high-frequency therapy equipment, including other Evis Exera devices as well as OES bronchofiberscopes.
Earlier that same year, the company was hit with a warning letter from the FDA that was issued in the wake of an inspection of one of Olympus’ Tokyo production sites.