Risk of burns to patient or user.
The manufacturer has identified that the blue COAG button on the CUSA® Excel CEM™ nosecone could stick in the 'activated' position.
This failure can occur whist the device is being used with the CUSA® Excel/Excel+ ultrasonic aspirator.
Integra Lifesciences is in the process of modifying the design to mitigate the risk of failure. The new design will not be available before the end of September 2014.
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