Events

Recall of CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Integra Neurosciences Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-01300-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01300-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Integra neurosciences has been notified by the manufacturer that there may be the potential that the blue coag button on the cusa excel cem nosecone could stick in the 'activated' position. a small number of complaints where this has occurred have been reported and of those, a smaller number resulted in tissue burn.
  • Action
    Integra is providing an Update to the Instructions for Use (IFU). Integra is advising users to replace nosecone if the COAG button is observed to be sticking and contact Integra. Integra is advising users to check the nosecone during setup and prior to patient use and replace nosecone if observed to be sticking. If the Nosecone is to be used in excess of approximately 30 minutes during surgery, Integra is advising to replace the nosecone after 30 minutes of activation.

Device

CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator
  • Model / Serial
    CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic AspiratorCatalogue Numbers: C6623 and C6636Lot Numbers: All lotsARTG Number: 197945
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd