BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 482606 · Received September 3, 2003

    Report

    Report Number
    1722040-2003-00012
    Event Type
    Malfunction
    Date Received
    September 3, 2003
    Date of Event
    August 26, 2003
    Report Date
    September 2, 2003
    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 REP REPORTED THE TIP BROKE OFF INSIDE THE PT DURING A PROCEDURE. THE TIP WAS RETRIEVED WITH GRASPERS. 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