BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX LASER FIBER

    MDR report key: 2092965 · Received May 5, 2011

    Report

    Report Number
    2937094-2011-00959
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 19, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K050108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE FIBER BROKE AT 5,792.80 JOULES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFLEX LASER FIBER SUREFLEX FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA TRF3579C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other