BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2001577 · Received January 26, 2011

    Report

    Report Number
    2937094-2010-01668
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    November 22, 2010
    Report Date
    January 21, 2011
    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)(4) 2010, THE FIBER FORWARD FIRED AND THERE WAS A SIGNIFICANT DECREASE IN VAPORIZATION AT 15,000 JOULES. NO PT INJURY WAS REPORTED. THIS INFO WAS PROVIDED ON (B)(4) 2011 WHICH RESULTED IN AN MDR BEING REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 930N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other