BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1843942 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00200
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 30, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THERE WAS FIBER CAP DETACHMENT AT 53,264 JOULES WHILE INSIDE THE PATIENT. ALL PIECES OF THE CAP WERE RETRIEVED AND NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    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 012H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other