BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED CORPORATION

    MDR report key: 483837 · Received July 3, 2003

    Report

    Report Number
    1720159-2003-00065
    Event Type
    Injury
    Date Received
    July 3, 2003
    Date of Event
    June 2, 2003
    Report Date
    June 5, 2003
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT CAME INTO SURGERY CRITICAL AND UNSTABLE. THE RESPIRATORY THERAPIST HEARD A POP/CRACK, THOUGHT TO BE UNDER THE DRAPES IN THE TORSO AREA. THE FLAME SEEMED TO JUMP AROUND. THE PT WAS ON THEIR BACK. THE MACROLYTE PREEMIE DISPERSIVE ELECTRODE WAS ON THE SMALL OF THE BACK WITH THE LEADS COMING OUT BETWEEN THE LEGS. THE POP SEEMED TO BE WHEN THE PENCIL WAS ACTIVATED. THERE WERE 1ST AND 2ND DEGREE BURNS TO THE NECK, HEAD AND GROIN- 5% OF THE PT'S BODY. PT LEFT SURGERY CRITICAL BUT STABLE. CO IS EXAMINING THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED CORPORATION * GEI CONMED ELECTROSURGERY EXCALIBUR PLUS PC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * #440-2400, LOT #0211011, EXP 11/2004, MANUFACTURED| MACROLYTE PREEMIE DISPERSIVE ELECTRODE, CATALOG| ELECTROSURGICAL PENCIL-MFG UNK.| BY CONMED.