BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION IRRIGATION ELECTRODE, J-HOOK TIP, ALLEGIANCE

    MDR report key: 5350608 · Received September 7, 2004

    Report

    Report Number
    1722040-2004-00016
    Event Type
    Malfunction
    Date Received
    September 7, 2004
    Date of Event
    August 6, 2004
    Report Date
    September 7, 2004
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED WITH TIP BENT AND LUMEN MATERIAL SPLITTING. A PIECE WAS MISSING FROM THE LUMEN. THE HOSPITAL REPORTED THIS WAS DETECTED BEFORE USE, BUT IF THIS OCCURRED DURING A PROCEDURE, A DELAY MIGHT BE NEEDED TO REMOVE THE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION IRRIGATION ELECTRODE, J-HOOK TIP, ALLEGIANCE LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES3664-30 ICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other