BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX FIBERS

    MDR report key: 3950087 · Received July 22, 2014

    Report

    Report Number
    2937094-2014-00649
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER TIP BROKE OFF INSIDE THE PATIENT. THE TIP WAS RETRIEVED WITHOUT PATIENT INCIDENT. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428919 SUREFLEX FIBERS POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) R-LLF365

    Patients

    Seq Age Sex Outcome Treatment
    1