BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2092981 · Received May 5, 2011

    Report

    Report Number
    2937094-2011-00958
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 18, 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 6,330 JOULES. PER THE CUSTOMER, THE PHYSICIAN COMPLETED THE PROCEDURE ALRIGHT ALTHOUGH IT TOOK A LONGER TIME TO REMOVE THE FIBER TIP FROM THE PT. ALSO, IT WAS REPORTED THE FIBER TIP WAS RETRIEVED.

    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 044H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other