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Medical Device Alert: CUSA CEM™ Nosecones for use with the CUSA® Excel/Excel+ Ultrasonic Aspirator Manufactured by Integra Lifesciences (MDA/2014/006)

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.

 

Action

  • Identify affected devices.
  • Ensure members of staff are aware of the advice and guidance detailed in the manufacturer's Field Safety Notice (195Kb) (FSN).
  • Have spare nosecones readily available for use.
  • Complete and return the manufacturer's acknowledgement form.
  • Use alternative devices where possible.
  • Report any adverse incidents to Integra Lifesciences and the MHRA.

Action by

  • Operating theatre staff.
  • Surgeons.
  • Supplies department staff.

 

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The Operating Theatre Journal, OTJ, is published monthly and distributed to every hospital operating theatre department in the UK. The distribution includes both the National Health Service and the Private Sector.

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