BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1915077 · Received November 17, 2010

    Report

    Report Number
    2937094-2010-01129
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, DURING THE PROCEDURE, A SUDDEN STRONG LIGHT CAME OUT OF THE TIP OF THE FIBER AND THE FIBER EFFICACY DECREASED CONSIDERABLY AT 30,000 JOULES. ALSO, IT WAS REPORTED THAT THIS WAS NOT CAUSED BY POOR TECHNIQUE AND THAT THIS OCCURRED AFTER FIVE MINS OF FIBER USAGE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other