More than 17,000 medical devices used to diagnose and treat the lungs and airways are being recalled.
The FDA says the bronchoscopy devices—broncho-fiberscopes and broncho-videoscopes—have caused four burn-based injuries and drawn almost 200 complaints for sparking or catching fire.
No deaths have been reported, but the agency is labeling the action a Class I recall, the most stern type.
The manufacturer, Olympus, alerted customers who own the scopes to the presence of the risk in October, FDA says.
The recall applies to 17,691 scopes distributed between Jan. 1, 2001, and Sept. 11, 2023.
Olympus pointed users to the warning section in the operator’s manual, highlighting steps to avoid adverse events. These include “stop performing high-frequency cauterization while supplying oxygen” and “keep electrosurgical devices used with the endoscope far enough away from the endoscope.”
FDA notice here.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.