BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1973784 · Received January 17, 2011

    Report

    Report Number
    2937094-2010-01579
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    AMS INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE LASER BEAM WAS SHOOTING OUT ON BOTH SIDES OF THE FIBER TIP AT 158 JOULES. ALSO, IT WAS REPORTED THAT THE FIBER DID NOT FIRE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS INNOVATION CENTER - SILICON VALLEY NA 030H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other