A recall of lung scopes from Olympus has been rated as Class I by the FDA, the agency’s most serious classification, after reports of fires and burns.
The recall spans more than 17,600 bronchoscopes distributed in the U.S. since 2001, including flexible, fiber-optic systems and video camera-equipped devices used to visualize a patient’s airway and deeper pockets within the lungs.
No products are being removed from the market or being returned to the manufacturer. Both the FDA and Olympus have issued safety and correction notices to healthcare providers.
In October, Olympus alerted its customers (PDF) that it had received 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.
The FDA said it has received a total of 192 complaints, including the four reported injuries, but has recorded no deaths related to the issue.
The agency reiterated Olympus’ warnings that providers should stop performing high-frequency cauterization while supplying oxygen—and to make sure that compatible electrosurgical devices are only being used when the electrodes are a safe distance away from the far end of the endoscope.
The four cases were each related to Olympus’ Evis Exera III bronchovideoscope with the model number BF-XT190. However, the company said that there are 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 this year, Olympus received a warning letter from the FDA over its endoscope manufacturing and safety report processes following a November 2022 inspection of one of its Tokyo facilities.
One case, according to the FDA, was related to an endoscope end cap that could potentially fall off while the device was inside a patient. The agency said Olympus did not implement adequate corrective actions and opted instead to simply monitor future device complaints. The FDA’s device center director, Jeff Shuren, issued a statement at the time, saying, “Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety.”
Olympus told Fierce Medtech in March that it planned to submit a “comprehensive response” to the letter within the 15 days allotted by the FDA.