BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1879647 · Received October 13, 2010

    Report

    Report Number
    2937094-2010-00740
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 15, 2010
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER FORWARD FIRED AT 50,476 JOULES. ALSO, IT WAS REPORTED THAT THE FIBER TIP WAS DAMAGED AND THE FIBER CAP DETACHED. ALSO, THE FIBER TIP/CAP WAS RETRIEVED. NO PATIENT INJURY WAS REPORTED. A DEVICE EVALUATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 014H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other