BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2090749 · Received April 26, 2011

    Report

    Report Number
    2937094-2011-00826
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 7, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER- SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 THE FIBER CAP DETACHED WHILE INSIDE OF THE PT AT 15,429 JOULES. ALSO, IT WAS REPORTED THAT ALL FIBER PIECES WERE RETRIEVED. NO PT 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 107A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other