BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM FIXED TIP ELECTRODE, 5MM REUSABLE - L-DIAMOND

    MDR report key: 536255 · Received March 18, 2004

    Report

    Report Number
    1722040-2004-00002
    Event Type
    Malfunction
    Date Received
    March 18, 2004
    Date of Event
    February 19, 2004
    Report Date
    March 18, 2004
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SALES REPRESENTATIVE REPORTED THE TIP BROKE OFF THE ELECTRODE DURING A PROCEDURE. ALL THE PARTS WERE RETRIEVED AND NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM FIXED TIP ELECTRODE, 5MM REUSABLE - L-DIAMOND LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES3511B GLA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other