BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2092574 · Received May 2, 2011

    Report

    Report Number
    2937094-2011-00895
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    October 26, 2010
    Report Date
    April 13, 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) 2010, THE FIBER WAS DAMAGED AT THE TIP AT 118,271 JOULES. ALSO, IT WAS REPORTED THE FIBER TIP BROKE AND INSIDE OF THE PATIENT. THE FIBER TIP WAS EXTRACTED FROM THE PATIENT.

    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 021H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other