BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM

    MDR report key: 6692819 · Received July 5, 2017

    Report

    Report Number
    MW5070841
    Event Type
    Malfunction
    Date Received
    July 5, 2017
    Date of Event
    June 21, 2017
    Report Date
    July 5, 2017
    Manufacturer
    AEM: ENCISION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SURGEON USING CAUTERY FOR LAPAROSCOPIC PROCEDURE, CAUTERY MACHINE MISFIRED - POSSIBLE HOLE IN INSULATION. PATIENT RECEIVED BURN INTRA-ABDOMINALLY. BOTH MACHINE AND CAUTERY INSTRUMENT USED WERE TAGGED AND SENT TO BIOMED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466122 AEM AEM AND L HOOK AEM CAUTERY GEI AEM: ENCISION AEM: 193981

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other