The affected devices include 15 types of bronchofiberscopes and bronchovideoscopes. They might combust 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,” the FDA said.
Olympus has received 192 complaints, four reports of injury and zero reports of death related to the issue.
The notice is not a product removal. Users of the devices are reminded to review the warning section in the device’s operations manual, which says the scopes should be far away from electrosurgical devices and only use compatible high-frequency equipment.
Customers should also stop performing high-frequency cauterization while supplying oxygen, according to the FDA.
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