BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1899497 · Received November 4, 2010

    Report

    Report Number
    2937094-2010-00940
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    TAX EXEMPT
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010 THE LASER BEAM FRONT FIRED AT 41,338 JOULES. AFTER A FEW JOULES WERE EMITTED, THE FIBER CAP DETERIORATED. THE PHYSICIAN PROCEEDED WITH USING TURP. ALSO, IT WAS REPORTED THAT THERE WAS A LOSS OF THE WATER COOLING SYSTEM. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX TAX EXEMPT NA 930Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Other