BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION IRRIGATION ELECTRODE, J-HOOK, ALLEGIANCE TRUMPET

    MDR report key: 736057 · Received June 30, 2005

    Report

    Report Number
    1722040-2005-00009
    Event Type
    Malfunction
    Date Received
    June 30, 2005
    Date of Event
    June 1, 2005
    Report Date
    June 30, 2005
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TIP CAME OFF OF THE SUCTION IRRIGATION ELECTRODE. IF IT HAD HAPPENED DURING THE PROCEDURE IT COULD MEAN A DELAY IN THE PROCEDURE TO RETRIEVE THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION IRRIGATION ELECTRODE, J-HOOK, ALLEGIANCE TRUMPET LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES3774 JA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other