BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED THERMOGARD DISPERSIVE ELECTRODE

    MDR report key: 1964248 · Received January 19, 2011

    Report

    Report Number
    1720159-2010-00076
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    November 26, 2010
    Report Date
    December 22, 2010
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K972628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONCLUSIVELY CONFIRMED SINCE THE DEVICE IN QUESTION IS NOT AVAILABLE FOR REVIEW. WITHOUT EVALUATING THE SUSPECTED SAMPLE A CONCLUSIVE DETERMINATION CANNOT BE MADE. THE DISPERSIVE ELECTRODE INSTRUCTIONS FOR USE STATE THE FOLLOWING: DIRECTIONS FOR USE: AFTER THE PATIENT IS IN THE FINAL POSITION, CAREFULLY SEPARATE THE ELECTRODE FROM THE LINER STARTING AT THE ELECTRODE EDGE FARTHEST FROM THE CABLE OR CABLE ATTACHMENT. AVOID EXCESS SKIN OR FINGER CONTACT WITH THE ADHESIVE SURFACE PRIOR TO APPLICATION. APPLY ELECTRODE FIRMLY, ENSURING FULL ADHESION AND CONTACT WITH THE SKIN. ELECTRODE SHOULD BE APPLIED SO THAT IT IS PERPENDICULAR TO THE DIRECTION OF CURRENT FLOW FROM THE OPERATIVE SITE. WARNINGS: FAILURE TO ACHIEVE GOOD SKIN CONTACT BY THE ENTIRE ADHESIVE SURFACE MAY RESULT IN AN ELECTROSURGICAL BURN OR POOR ELECTROSURGICAL PERFORMANCE. APPARENT LOW POWER OUTPUT OR FAILURE OF THE ELECTROSURGICAL EQUIPMENT TO FUNCTION CORRECTLY AT NORMAL SETTINGS MAY INDICATE FAULTY APPLICATION OF THE DISPERSIVE ELECTRODE OR FAILURE OF AN ELECTRICAL LEAD. DO NOT INCREASE POWER OUPUT BEFORE CHECKING FOR ELECTRODE APPLICATION AND INTEGRITY. DO NOT REUSE OR RELOCATE THE DISPERSIVE ELECTRODE AFTER INITIAL APPLICATION. IF PATIENT IS REPOSITIONED DURING PROCEDURE, REINSPECT DISPERSIVE ELECTRODE AND ALL CONNECTORS. IF DISPERSIVE ELECTRODE RELOCATION BECOMES NECESSARY DURING THE PROCEDURE, USE A NEW ELECTRODE: DO NOT ATTEMPT TO REUSE A DISPERSIVE ELECTRODE ONCE IT HAS BEEN APPLIED TO A PATIENT. USER FACILITY DISCARDED SUSPECT DEVICE.

    Description of Event or Problem · 1

    USER FACILITY REPORTED TWO (2) BURNS AS SECOND DEGREE BURNS AT OPPOSITE SIDES OF THE PAD (CORD SIDE AND OPPOSITE). BOTH BURNS TREATED WITH SILVADENE CREME AND REPORTED NO FURTHER TREATMENT NECESSARY. PAD WAS APPLIED TO LEG, LEG WAS IN STIRRUPS, STAFF IN OR STATED APPEARS AS IF PAD SEPARATED FROM PATIENT. TECH IN OR SAID PAD WAS BUNCHED UP ON BACK. PATIENT IS SAID TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED THERMOGARD DISPERSIVE ELECTRODE ELECTROSURGICAL GROUNDING PAD GEI CONMED ELECTROSURGERY UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other