BEUDAMED
    FDA Adverse Event Summary report: N

    AEM ELECTRODE

    MDR report key: 2140681 · Received June 10, 2011

    Report

    Report Number
    2140681
    Date Received
    June 10, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A SURGICAL PROCEDURE, THE SCREW THAT ATTACHED THE ESU ELECTROSURGICAL UNIT HOOK DISCONNECTED FROM THE HOOK AND STAYED IN THE DISPOSABLE MONOPOLAR CORD. THE MONOPOLAR CORD FELL ON THE PATIENT'S SKIN WHILE THE ESU WAS ACTIVATED. THE PATIENT SUFFERED THREE 3MM SECOND DEGREE BURN IN THE AREA OF THE RIGHT LOWER QUADRANT MEDIALLY, UPPER PORTION. THE ENTIRE SYSTEM WAS EXCHANGED AND A NEW SYSTEM WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM ELECTRODE L-DIAMOND ELECTRODE GEI ENCISION, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR