BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT PV ADDSTAT

    MDR report key: 2172169 · Received June 15, 2011

    Report

    Report Number
    2937094-2011-01214
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    April 13, 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 5,954 JOULES. 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 937P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other