BEUDAMED
    FDA Adverse Event Other Summary report: N

    5MM AEM HANDLE ASSEMBLY

    MDR report key: 582095 · Received March 15, 2005

    Report

    Report Number
    1722040-2005-00007
    Event Type
    Other
    Date Received
    March 15, 2005
    Date of Event
    February 25, 2005
    Report Date
    March 14, 2005
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON BELIEVES THAT ENERGY WAS RELEASED ALONG THE SHAFT OF THE INSTRUMENT CAUSING AN UNINTENDED BURN TO THE PATIENT'S UTERUS. DURING THE TUBAL LIGATION PROCEDURE FOR THE USER WAS RECEIVING REM ALARMS ADN REPLACED THE REM PAD. AFTER CHANGING PADS, THE SURGEON ACTIVATED THE FOOTSWITCH TO ENSURE THAT THE CAUTERY WAS WORKING. UPON CONTINUING THE PROCEDURE, TEH BURN WAS DISCOVERED. ACCORDING TO STATEMENT BY NURSING STAFF TO THE TERRITORIAL SALES MANAGER, THE BURN SHAPE RESEMBLED THE INSTRUMENT TIP SHAPE AND APPEARED AS THOUGH THE TIP WAS RESTING ON THE UTERUS DURING ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM AEM HANDLE ASSEMBLY LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES5700E JK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention