BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1890836 · Received October 28, 2010

    Report

    Report Number
    2937094-2010-00920
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 1, 2010
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER TIP MELTED/WITHERED AN INCH FROM THE TIP OF THE FIBER AT 76,185 JOULES. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 020H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other