BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEM FIXED TIP ELECTRODE, 5MM-REUSABLE, L-WEDGE

    MDR report key: 806780 · Received January 12, 2007

    Report

    Report Number
    1722040-2007-00001
    Event Type
    Injury
    Date Received
    January 12, 2007
    Date of Event
    December 26, 2006
    Report Date
    January 12, 2007
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    PMA / PMN Number
    K912780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OBSERVED A SMALL AMOUNT OF DAMAGE TO THE TIP INSULATION, WHICH IS AN END OF LIFE INDICATOR FOR THE INSTRUMENT. THERE WAS NO VISIBLE DAMAGE TO THE OUTER INSULATION OF THE SHAFT TO INDICATING ARCING FROM THE SHAFT, AND THE INNER AND OUTER INSULATION PASSED TESTS OF THE DIELECTRIC STRENGTH SPECIFICATIONS. THE NATURE AND CAUSE OF THE INJURY COULD NOT BE DETERMINED FROM THE AVAILABLE DATA. HOWEVER, DAMAGE TO TISSUE CAN OCCUR FROM CONTACT OF THE ACTIVATED TIP WITH UNINTENDED TISSUE. INSTRUCTIONS FOR THE USE STATE THE SURGEON SHOULD MAINTAIN THE AREA OF THE TIP IN HIS/HER FIELD OF VIEW.

    Description of Event or Problem · 1

    L-WEDGE FIXED TIP ELECTRODE WAS BEING USED TO MOVE THE LIVER AND A BURN ON THE LIVER WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM FIXED TIP ELECTRODE, 5MM-REUSABLE, L-WEDGE LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES3512B LA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other