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Early Alert: Flexible Cryoprobe Issue from Erbe USA
The FDA is aware Erbe USA has reported instances of certain Cryoprobes rupturing or bursting during activation. The rupture is caused by insufficient adhesive being applied during production, leading to excessive input pressure.
The rupture causes a loud sound which could cause tinnitus, temporary hearing loss, or persistent hearing loss to patients, healthcare professionals, or any person near the device when activated. The rupture of the device may also lead to injuries and burns.
As of February 24, Erbe USA has reported five serious injuries and no deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Erbe USA at 770-955-4400.
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