Olympus Bronchoscopes Recalled Due to Laser Therapy Risks
This recall was posted 5 months ago. Check the FDA source for the latest status.
Class I Recall — Most Serious
This is a Class I recall — the most serious type. Products covered by this recall may cause serious health consequences or death.
Reported Health Impact
4
Illnesses
1
Death
Olympus Corporation has issued a voluntary recall for certain bronchoscopes due to potential risks when used with laser therapy and similar equipment. This recall aims to update the safety instructions for these medical devices.
Products Affected:
- Bronchofiberscopes
- Bronchovideoscopes
Reason for Recall:
The recall was initiated due to the risk of endobronchial combustion, which can occur during procedures involving laser therapy, argon plasma coagulation, or high-frequency cauterization. This risk is heightened when oxygen levels exceed 40% or when the equipment is used too close to the endoscope.
Health Risks:
Endobronchial combustion can cause severe internal burns to the airway or lungs, potentially leading to additional medical interventions, extended hospital stays, or even death. There have been reports of serious injuries, including one fatality.
What Consumers Should Do:
Healthcare providers should ensure all staff are fully informed of the updated instructions for use. Key recommendations include maintaining a separation of more than 4cm between the endoscope and the endotracheal tube, keeping oxygen levels below 40%, limiting energy output to less than 40 watts, avoiding excessive energy in one spot, and using suction to remove smoke.
For further information or to report issues, contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1, or email [email protected]. Adverse reactions can also be reported to the FDA's MedWatch program.
Where Products Were Sold
This recall affects products distributed nationwide across the United States.