BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEM FIXED TIP ELECTRODE, 5MM-REUSABLE, L-WEDGE, 45CM

    MDR report key: 470713 · Received July 2, 2003

    Report

    Report Number
    1722040-2003-00009
    Event Type
    Other
    Date Received
    July 2, 2003
    Date of Event
    June 16, 2003
    Report Date
    July 2, 2003
    Manufacturer
    ENCISION INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE THE SURGEON NOTICED BURNING OF TISSUE APPROXIMATELY 2 CM BACK FROM THE TIP OF THE FIXED TIP ELECTRODE, WHEN THERE WAS NO ENERGY AT THE TIP. TISSUE DAMAGE WAS MINIMAL AND NO SERIOUS PT INJURY WAS REPORTED, BUT THERE WAS CONCERN OF POTENTIAL SERIOUS INJURY IF THE EVENT WERE TO RECUR. A NOTE ON THE RETURNED DEVICE ALSO EXPRESSED CONCERN THAT THE AEM MONITOR DID NOT SHUT DOWN THE ELECTROSURGICAL GENERATOR AS THE USER EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM FIXED TIP ELECTRODE, 5MM-REUSABLE, L-WEDGE, 45CM LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION INC. ES3512-45 GB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other