BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION IRRIGATION ELECTRODE, L-DIAMOND, ALLEGIANCE TRUMPET

    MDR report key: 609954 · Received March 22, 2004

    Report

    Report Number
    1722040-2004-00004
    Event Type
    Malfunction
    Date Received
    March 22, 2004
    Date of Event
    January 26, 2004
    Report Date
    March 22, 2004
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THE TIP CAME OFF THE SUCTION/IRRIGATION ELECTRODE DURING CLEANING. IF IT HAD HAPPENED DURING USE IT COULD MEAN A DELAY IN THE PROCEDURE TO RETRIEVE THE PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION IRRIGATION ELECTRODE, L-DIAMOND, ALLEGIANCE TRUMPET LAPARASCOPIC ELETROSURGICAL DEVICE GEI ENCISION, INC. ES3771 IJ

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other