BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED GOLDVAC PUSH BUTTON SMOKE EVAC. PENCIL

    MDR report key: 2243630 · Received July 27, 2011

    Report

    Report Number
    1720159-2011-00045
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED AND EVALUATED BY CONMED. THE RETURNED HANDPIECE WAS SUBJECTED TO AN ELECTROSURGICAL UNIT INTERFACE TEST WHICH SIMULATES ACTUAL USE. THE REPORTED MALFUNCTION COULD NOT BE REPRODUCED. OUR INSTRUCTIONS FOR USE (IFU) STATES UNDER 'SAFETY TIPS' THAT "THE GOLDVAC PENCILS ARE NOT INTENDED TO SUCTION FLUIDS FROM THE SURGICAL SITE." CONMED'S INVESTIGATOR NOTED THAT THERE WAS SOME BLOOD INSIDE THE CORRUGATED TUBING. ADDITIONALLY, IT WAS OBSERVED THAT SOME OF THE INTERNAL COMPONENTS WERE WET.

    Description of Event or Problem · 1

    THE HANDPIECE KEPT FIRING WHEN THE HANDPIECE WAS NOT ENGAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED GOLDVAC PUSH BUTTON SMOKE EVAC. PENCIL ELECTROSURGICAL PENCIL/GEI GEI CONMED ELECTROSURGERY NA 1105233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other