Events

Alerte Ou Avis De Sécurité sur CUSA CEM™ nosecones for use with the CUSA® Excel/Excel+ ultrasonic aspirator

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Integra Lifesciences.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2014/006
  • Numéro de l'événement
    CON383409
  • Date
    2014-02-26
  • Date de publication de l'événement
    2014-02-26
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON383409?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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