BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENCISION DISPOSABLE AEM CORD

    MDR report key: 540409 · Received August 10, 2004

    Report

    Report Number
    540409
    Event Type
    Other
    Date Received
    August 10, 2004
    Date of Event
    August 2, 2004
    Report Date
    August 10, 2004
    Manufacturer
    ENCISION, INC
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DISPOSABLE AEM, ACTIVE ELECTRODE MONITOR, CORD WAS ATTACHED TO A LAPAROSCOPIC CAUTERY DEVICE AND WHEN THE SURGEON ACTIVATED THE CAUTERY THE REM, RETURN ELECTRODE MONITOR, ALARM ON THE VALLEY LAB BOVIE SOUNDED WITH EACH ATTEMPT AT ACTIVATION. THE BOVIE CORD WAS SWITCHED OUT AND REPLACED WITH A NEW CORD AND THE REM ALARM NO LONGER ALARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCISION DISPOSABLE AEM CORD ELECTROCAUTERY CORD GEI ENCISION, INC * JF

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR