BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX FIBERS

    MDR report key: 3790706 · Received May 5, 2014

    Report

    Report Number
    2937094-2014-00341
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE FIBER "SPARKED AND HAD A SHORT." THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. ADDITIONAL INFORMATION NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266597 SUREFLEX FIBERS POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) S-LLF365

    Patients

    Seq Age Sex Outcome Treatment
    1