Events

Safety Alert Or Field Safety Notices for CUSA CEM™ nosecones for use with the CUSA® Excel/Excel+ ultrasonic aspirator

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Integra Lifesciences.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/006
  • Event Number
    CON383409
  • Date
    2014-02-26
  • Event Date Posted
    2014-02-26
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON383409?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    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 (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.

Device

CUSA CEM™ nosecones for use with the CUSA® Excel/Excel+ ultrasonic aspirator
  • Model / Serial
  • Product Description
    Electrosurgical devices. CUSA CEM™ nosecones for use with the CUSA® Excel/Excel+ ultrasonic aspirator. Product codes: C6623 and C6636.
  • Manufacturer
    Integra Lifesciences

Manufacturer

Integra Lifesciences