BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT PV ADDSTAT

    MDR report key: 2172170 · Received June 15, 2011

    Report

    Report Number
    2937094-2011-01215
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 19, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K010284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THERE WAS DIMINISHED FIBER TISSUE VAPORIZATION AT 16,565 JOULES. ALSO, IT WAS REPORTED THE PROCEDURE WAS COMPLETED WITH TURP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT PV ADDSTAT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA 913E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other