Olympus Corporation of the Americas (Olympus) is recalling certain bronchofiberscopes and bronchovideoscopes because they may lead to burns or catch fire, according to a safety communication from the US Food and Drug Administration (FDA).
The FDA has identified this as a class I recall, the most serious type of recall.
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.
On Oct 12, 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.
Full List of Affected Devices
| Bronchovideoscope Olympus BF Type 1T150 | Evis Exera II Bronchovideoscope Olympus BF Type 1T180 |
| OES Bronchofiberscope Olympus BF Type 1T60 | Evis Exera III Bronchovideoscope Olympus BF-1TH190 |
| Evis Exera II Bronchovideoscope Olympus BF Type 1TQ180 | Evis Exera III Bronchovideoscope Olympus BF-H190 |
| Bronchovideoscope Olympus BF Type P150 | Evis Exera II Bronchovideoscope Olympus BF Type P180 |
| Evis Exera III Bronchovideoscope Olympus BF-P190 | OES Bronchofiberscope Olympus BF Type P60 |
| Bronchovideoscope Olympus BF-Q170 | Evis Exera II Bronchovideoscope Olympus BF Type Q180-AC |
| Evis Exera III Bronchovideoscope Olympus BF-Q190 | Evis Exera Bronchovideoscope Olympus BF Type XT160 |
| Evis Exera III Bronchovideoscope Olympus BF-XT190 | |
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
