BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST

    MDR report key: 1920183 · Received November 14, 2010

    Report

    Report Number
    1920183
    Event Type
    Malfunction
    Date Received
    November 14, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 14, 2010
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO PLUG IN HAND PIECE TO VNUS MACHINE AND IT WOULD NOT PLUG IN. FOUND PRONGS ON HANDPIECE TO BE BENT. HANDPIECE REMOVED FROM FIELD AND REPLACE WITH NEW HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSUREFAST RADIOFREQUENCY CATHETER GEI VNUS MEDICAL TECHNOLOGIES, INC 7FR CATHETER 514764

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR