Events

Alerta De Seguridad O Notificaciones De Seguridad para CUSA CEM™ nosecones for use with the CUSA® Excel/Excel+ ultrasonic aspirator

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Integra Lifesciences.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2014/006
  • Número del evento
    CON383409
  • Fecha
    2014-02-26
  • Fecha de publicación del evento
    2014-02-26
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON383409?tabName=allTabs
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    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