BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEM LAPAROSCOPIC FIXED-TIP ELECTRODE

    MDR report key: 2562843 · Received May 1, 2012

    Report

    Report Number
    1722040-2012-00002
    Event Type
    Injury
    Date Received
    May 1, 2012
    Date of Event
    March 30, 2012
    Report Date
    March 30, 2012
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    PMA / PMN Number
    K912780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PROMISED TO BE RETURNED BY FACILITY, BUT NOT RETURNED BEFORE DEADLINE TO REPORT EVENT. DISCUSSIONS WITH INITIAL REPORTER LEAD US TO BELIEVE END-OF-LIFE INDICATION OF FRAYED INSULATION AT TIP WAS IGNORED RESULTING IN ARCING DURING THE PROCEDURE THAT CAUSED THE BURN.

    Description of Event or Problem · 1

    INSTRUMENT ARCED DURING LAPAROSCOPIC CHOLECYSTECTOMY CAUSING BURN ON LIVER BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM LAPAROSCOPIC FIXED-TIP ELECTRODE ELECTROSURGICAL CUTTING AND COAG DEVICE GEI ENCISION, INC. ES 3512B QF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other