BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM FIXED TIP ELECTRODE, 5MM-REUSABLE, J-HOOK, 45CM

    MDR report key: 470520 · Received July 2, 2003

    Report

    Report Number
    1722040-2003-00010
    Event Type
    Malfunction
    Date Received
    July 2, 2003
    Date of Event
    June 20, 2003
    Report Date
    July 2, 2003
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THE SURGEON OBSERVED CAUTERIZATION OF TISSUE ABOUT 2 CM BACK FROM THE TIP OF THE FIXED TIP ELECTRODE, DURING A GASTRIC BYPASS PROCEDURE. THIS PROBLEM HAS NOT BEEN ENCOUNTERED ON THE SHORTER INSTRUMENTS. NO SERIOUS PATIENT INJURY WAS REPORTED BUT THERE WAS A STATED CONCERN OF SERIOUS INJURY IF THE EVENT RECURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM FIXED TIP ELECTRODE, 5MM-REUSABLE, J-HOOK, 45CM LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES3510-45 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other