BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2172146 · Received June 15, 2011

    Report

    Report Number
    2937094-2011-01222
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THERE WAS A BRIGHT FLASH AND A LOSS OF VAPORIZATION FROM THE FIBER AT 64,189 JOULES. PER THE CUSTOMER, THIS WAS DUE TO BURIED UNDETECTABLE PROSTATIC CALCULI. ALSO, THE CUSTOMER REPORTED THE FIBER HAD GOOD IRRIGATION FLOW. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA 049H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other