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Olympus bronchoscopes compatible with high-frequency therapy equipment during therapeutic procedures, the FDA said in a Class I recall notice.

The 15 models of bronchofiberscopes and bronchovideoscopes in question are not being pulled from the market, but rather a has been put in place by the company to make sure providers review the devices' safety warnings and are aware of combustion risks when "high-frequency cauterization is performed while supplying oxygen" or if "the electrode section of an electrosurgical accessory is too close to the end of the endoscope," the agency said.

Serious health problems related to the issue include "critical burns in a person's airways or lungs, airway bleeding, trouble breathing, apnea, loss of consciousness, or death," according to the announcement. "Injuries may lead to prolonged procedures, additional medical care, extended hospitalization, ICU care, and death. Combustion can damage or break parts of the device that may injure or unintentionally remain in the patient and may require retrieval or surgical removal."

So far, 192 complaints, four injuries, but no deaths have been reported in relation to the problem. Since 2001, more than 17,500 units of the 15 models have been distributed across the U.S.

Bronchoscopies are often performed to examine the airways for issues like a persistent cough or when imaging picks up an abnormality, but can also be performed for biopsies, placing stents, and therapeutic reasons such as pulmonary bleeding, strictures, or a collapsed lung.

One in FDA's Manufacturer and User Facility Device Experience (MAUDE) database involved a patient undergoing a diathermy in conjunction with Olympus' EVIS EXERA III Bronchovideoscope BF-XT190 model. "The probe caught fire and the patient sustained a burn in their lungs," according to the report.

Olympus said it has received four adverse event complaints of combustion during therapeutic procedures with that BF-XT190 model. One involved high-frequency therapy equipment while the three others involved unknown equipment that delivers energy therapy.

The corrective action from Olympus instructs users to review the warning section of the bronchoscopes' manuals and to "stop performing high-frequency cauterization while supplying oxygen," "keep electrosurgical devices used with the endoscope far enough away from the endoscope," and to "only use high-frequency equipment that is compatible with the Olympus bronchoscope, as listed in the operations manual."

The company said this recall and corrective action is unrelated to a , which led to a similar action earlier this year following complaints of serious injury, including one death.

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