The FDA labeled a recall of Olympus bronchoscopes that could lead to burns or fire Class I, the most serious kind.
Olympus reports 192 complaints related to the issue, including four injuries. The company has received no reports of death.
This recall — a correction, not a product removal — applies to Olympus bronchofiberscopes and bronchovideoscopes. The company distributed affected devices between Jan. 1, 2001, and Sept. 11, 2023 before initiating the recall on Oct. 12. In total, the recall affects 17,691 devices in the U.S.
Olympus scopes in the recall work with accessories and cameras and lights to examine or treat a person’s airways. Olympus recalled certain scopes because they may lead to burns or catch fire.
Using affected scopes could cause serious health consequences, including critical burns in a person’s airways or lungs. It could also lead to airway bleeding, trouble breathing, apnea, loss of consciousness or death. Combustion can damage or break parts of the device that may injure or unintentionally remain in the patient. This could require retrieval or surgical removal.
Affected scopes have a risk of combustion if high-frequency cauterization is performed while supplying oxygen or the electrode section of an electrosurgical accessory is too close to the end of the endoscope.
Olympus’ urgent medical device corrective action asked customers to review the warning section of the device’s operations manual. Users should stop performing high-frequency cauterization while supplying oxygen. They should also keep electrosurgical devices used with the endoscope far enough away from the endoscope.
Additionally, users should only use high-frequency that has compatibility with the Olympus bronchoscope.