The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Please be aware, this recall is a correction, not a product removal.
Recalled Product
- Product Names: Olympus bronchofiberscopes and bronchovideoscopes
- Product Codes: See Recall Database Entry
- Model Numbers: See full list
- Distribution Dates: January 1, 2001 to September 11, 2023
- Devices Recalled in the U.S.: 17,691
- Date Initiated by Firm: October 12, 2023
Device Use
The bronchofiberscopes and brochovideoscopes are tubular devices that work with accessories like cameras and lights to examine or treat a person’s airways.
Reason for Recall
Olympus Corporation of the Americas (Olympus) is recalling certain bronchofiberscopes and bronchovideoscopes because they may lead to burns or catch fire.
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.
There have been 192 complaints regarding this issue, including four injuries. There have been no deaths reported.
There is 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.
Who May be Affected
- People who are being treated with Olympus bronchofiberscopes or bronchovideoscopes
- Health care workers who use the scopes
What to Do
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.
