BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED GOLDLINE 'A' ROCKER SWITCH PENCIL

    MDR report key: 2152856 · Received June 28, 2011

    Report

    Report Number
    1720159-2011-00036
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 29, 2011
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PENCIL TAKEN FROM THE SURGICAL PACK WAS PLUGGED INTO THE GENERATOR AND IT AUTOMATICALLY STARTED TO ACTIVATE WITHOUT THE DEPRESSION OF THE ROCKER SWITCH. THE PENCIL REMAINED ACTIVATED WHEN THE FACILITY TRIED TO PUSH THE ROCKER SWITCH TO RELEASE THE BUTTON ACTIVATION. THE ELECTRODE WAS REMOVED FOR SAFETY AND THE FACILITY STILL COULD NOT GET THE PENCIL TO STOP ACTIVATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED GOLDLINE 'A' ROCKER SWITCH PENCIL ELECTROSURGICAL PENCIL, PRODUCT CODE: GEI GEI CONMED ELECTROSURGERY NA 1008275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other