Events

Alerte Ou Avis De Sécurité sur Footswitches for use with all models of ConMed or Valleylab electrosurgical units (ESUs)

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 N/A.

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/2005/061
  • Numéro de l'événement
    CON2022492
  • Date
    2005-11-04
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2022492
  • 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
    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.
  • Action
    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)
  • Modèle / numéro de série
  • Description du dispositif
    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