BEUDAMED
    FDA Adverse Event Death Summary report: N

    AEM FIXED TIP ELECTRODE, REUSABLE, J-HOOK

    MDR report key: 1644336 · Received March 29, 2010

    Report

    Report Number
    1722040-2010-00002
    Event Type
    Death
    Date Received
    March 29, 2010
    Date of Event
    May 1, 2008
    Report Date
    March 19, 2010
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    PMA / PMN Number
    K912780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER WILL TO TRY TO OBTAIN CONFIRMATION AND DETAILS ABOUT THE PT, THE EVENT, AND THE LOT CODE OF THE DEVICE FROM THE HOSPITAL WHERE THE ALLEGED INJURY OCCURRED.

    Description of Event or Problem · 1

    MANUFACTURER HAS BEEN INFORMED OF A PT DEATH ALLEGED TO BE CAUSED BY PERITONITIS RESULTING FROM A BURN INJURY TO THE STOMACH, DURING A LAPAROSCOPIC CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM FIXED TIP ELECTRODE, REUSABLE, J-HOOK LAPAROSCOPIC SURGICAL DEVICE GEI ENCISION, INC. ES3510B UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death