Events

Alerta De Seguridad O Notificaciones De Seguridad para Footswitches for use with all models of ConMed or Valleylab electrosurgical units (ESUs)

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 N/A.

¿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/2005/061
  • Número del evento
    CON2022492
  • Fecha
    2005-11-04
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2022492
  • 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
    Conmed and valleylab esus share the same type of footswitch connector but are wired differently. if the footswitches intended for one type of esu are used with the other, the esu will deliver 'cut' waveforms when the 'coagulate' footswitch is depressed, or 'coagulate' waveforms when the 'cut' footswitch is depressed.
  • Acción
    Theatre staff should check, before use, that footswitches operate cut and coagulate outputs correctly as advised in the manufacturer's instructions for use. Maintenance staff should ensure that all footswitches are labeled for use with the appropriate ESU. Staff should, as part of planned preventative maintenance, check that footswitches operate the correct cut and coagulate outputs. Report to the MHRA and the manufacturer any instance where the labelling is not sufficient. ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines. Further information about SABS can be found at: www.info.doh.gov.uk/sar/cmopatie.nsf

Device

Footswitches for use with all models of ConMed or Valleylab electrosurgical units (ESUs)
  • Modelo / Serial
  • Descripción del producto
    Footswitches for use with all models of ConMed or Valleylab electrosurgical units (ESUs), including footswitches manufactured by third parties.
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    MHRA