BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED ELECTROSURGICAL DISPERSIVE ELECTRODE

    MDR report key: 115111 · Received August 25, 1997

    Report

    Report Number
    1317214-1997-00103
    Event Type
    Injury
    Date Received
    August 25, 1997
    Date of Event
    July 23, 1997
    Report Date
    July 28, 1997
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PT REC'D 1 SQ. CM. OF BURNING, 2ND DEGREE, DURING AN OPERATION OF A TIBIOFIBULAR ON THE RIGHT LEG. THE SPOT TURNED BLACK AND CARBONIZED. A NURSE PUT THIS GROUND PAD ON THE LEFT THIGH WITHOUT SHAVING EXCESSIVELY HAIRY. AT THE POWER OF 40W, THIS PT COMPLAINED ABOUT NUMBNESS. WHEN THE ESU POWER WAS RAISED TO 50W, HE COMPLAINED OF STRONG PAD AT THE AREA OF THE GROUND PAD. THE NURSE FOUND THE BURNING, THE GROUND PAD WAS PLACED PROPERLY AND NOTHING WRONG WAS FOUND ON THE GROUND PAD. THIS MACHINE HAS A FUNCTION/CAPABILITY OF ALARM BUT DID NOT ALARM DURING THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL DISPERSIVE ELECTRODE DISPERSIVE ELECTORDE GEI CONMED CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention ESU