BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 439265 · Received January 16, 2003

    Report

    Report Number
    1722040-2003-00002
    Event Type
    Malfunction
    Date Received
    January 16, 2003
    Date of Event
    January 6, 2003
    Report Date
    January 16, 2003
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSP FOUND THE TIP LOOSE ON AN L-DIAMOND ELECTRODE. THEY STATED THAT ONE OF TWO PREVIOUS UNREPORTED SIMILAR EVENTS THE TIP CAME OFF DURING A LAPAROSCOPIC PROCEDURE.

    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 GIA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other