Olympus Broncoscope Recall Issued After Fire Injuries

Olympus is recalling nearly 18,000 bronchoscope medical tubes used to diagnose and treat lung conditions, after they were linked to nearly 200 surgical fires in operating rooms.

The U.S. Food and Drug Administration (FDA) announced the Olympus bronchofiberscope and bronchovideoscope recall on December 19, indicating that the agency has become aware of at least 192 complaints involving the tubes catching on fire during bronchoscopy procedures, which has resulted in at least four burn injuries.

Bronchoscopes are long, thin, flexible tubes inserted through the mouth or nose. They are used to examine the airways and lungs with cameras, lights, and other surgical accessories. Bronchofiberscopes are commonly used to diagnose or treat lung infections, pneumonia, lung cancer, and take biopsies using images transmitted through a fiberoptic bundle. Bronchovideoscopes inspect the airways using video imaging displayed on a monitor.

Officials warn the recalled bronchoscopes may catch on fire if high-frequency cauterization is used to burn off or close body tissue while supplying oxygen, or if they are too close to an electrosurgical accessory, such as an electrode.

The tubes can cause critical internal burn injuries to the airways or lungs, which may lead to prolonged procedures, extended hospitalization, additional or intensive medical care, or even death. They can also break apart or become damaged in the event of a fire and injure patients, or leave pieces of the device inside of a patient’s body, which may require surgery to remove.

Olympus Bronchofiberscope and Bronchovideoscope Recall

The recall impacts approximately 17,691 Olympus BF series bronchofiberscopes and bronchovideoscopes, and includes certain OES bronchofiberscope models, as well as certain Evis Exera I, II, and III bronchovideoscope models. They were distributed from January 1, 2001 until September 11, 2023.

According to the recall, Olympus sent an urgent letter to customers in October, recommending that they only use compatible high-frequency equipment, keep electrosurgical devices far away from the bronchoscopes, and stop performing high-frequency cauterization while supplying oxygen.

The company considers its actions a product correction, and not a complete removal, however, the FDA has designated the action as a Class I recall, indicating that patients face an increased risk of sustaining serious or fatal injuries with continued use of the devices.

For more information, consumers may contact Olympus by phone at 1-800-848-9024, and select option one.

Health care professionals and consumers are also encouraged to report any adverse side effects or reactions they experienced while using the devices to the FDA MedWatch Adverse Event Reporting Program.

Surgical Fire Risks

Surgical fires occur in, on, or around patients undergoing medical or surgical procedures. While they are preventable, and normally rare, the FDA estimates that between 550 to 650 occur every year in the U.S.

Thee potentially deadly fires occur when three elements are present; an oxidizer, an ignition source, and fuel source. Operating rooms can become oxygen enriched when the concentration of oxygen exceeds 30 percent. Most surgical fires occur in oxygen-enriched environments and typically involve electrosurgical tools or lasers.

Surgical tools, including electrodes, can become ignition sources if a patient is simultaneously receiving oxygen and cause severe burn injuries. More than half of reported surgical fires result in procedure delays or additional treatment, and serious injuries can lead to permanent disfigurement, and even death. The most serious and fatal injuries involved airway fires, which occur when a fire starts in an attached breathing circuit, and shoots flames in the patient’s airways.