BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2060929 · Received March 14, 2011

    Report

    Report Number
    2937094-2011-00427
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 25, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    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 THE FIBER CAP DETACHED AT 13,009 JOULES. ALSO, IT WAS REPORTED THAT THE FIBER CAP WAS RETRIEVED. 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 017H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other