BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1941025 · Received December 22, 2010

    Report

    Report Number
    2937094-2010-01373
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    August 24, 2010
    Report Date
    November 29, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER LASER BEAM WENT FORWARD AND NOT SIDEWAYS AT 60,000 JOULES. ALSO, IT WAS REPORTED THAT THERE WAS A DEGRADATION OF THE FIBER, REDUCING THE EFFICIENCY AND CHANGING THE DIRECTION OF THE LASER BEAM.

    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 945K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other