The FDA issued an early alert regarding certain Erbe USA flexible cryoprobes after five serious injuries were reported due to device rupture.
On Feb. 12, Erbe USA notified customers to stop using affected products and quarantine devices from four part numbers: 20402-401, 20402-402, 20402-410 and 20402-411, according to a March 10 FDA update.
The ruptures are linked to insufficient adhesive applied during manufacturing, which can cause excessive input pressure during activation. Affected devices may produce a loud sound when rupturing, potentially leading to tinnitus, temporary or permanent hearing loss and burns or other injuries.
Flexible cryoprobes are used during interventional procedures for the palliative devitalization of tissue, foreign body removal and biopsies. Customers have been advised to examine inventory, quarantine affected devices and distribute the notification to any additional locations where the devices may have been used.
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