Olympus Corporation of the Americas is recalling certain bronchofiberscopes and bronchovideoscopes because they may lead to burns or catch fire. The recall encompasses 17,691 devices in the U.S.
Using the affected bronchoscopes may cause serious adverse health consequences, including critical burns in a person’s airways or lungs, airway bleeding, trouble breathing, apnea, loss of consciousness, or death. 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.
The bronchofiberscopes and brochovideoscopes are tubular devices that work with accessories like cameras and lights to examine or treat a person’s airways.
There have been 192 complaints regarding this issue, including four injuries. There have been no deaths reported. The FDA has identified this as a Class I recall, the most serious type of recall, meaning that use of these devices may cause serious injuries or death.
There is a risk of combustion if:
- High-frequency cauterization is performed while supplying oxygen
- The electrode section of an electrosurgical accessory is too close to the end of the endoscope
Prior to the full recall, on October 12, 2023, Olympus sent all affected customers an Urgent Medical Device Corrective Action.
The letter asked customers to review the warning section in the device’s operations manual, especially:
- Stop performing high-frequency cauterization while supplying oxygen.
- Keep electrosurgical devices used with the endoscope far enough away from the endoscope.
- Only use high-frequency equipment that is compatible with the Olympus bronchoscope, as listed in the operations manual.
