Events

Safety Alert Or Field Safety Notices for Footswitches for use with all models of ConMed or Valleylab electrosurgical units (ESUs)

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 N/A.

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/2005/061
  • Event Number
    CON2022492
  • Date
    2005-11-04
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2022492
  • 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
    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)
  • Model / Serial
  • Product Description
    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