BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX FIBERS

    MDR report key: 4092910 · Received September 16, 2014

    Report

    Report Number
    2937094-2014-00838
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 8, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER HEAD BROKE OUTSIDE THE PATIENT. NO OTHER INFORMATION AVAILABLE. THERE WAS ¿NO DAMAGE TO THE PATIENT¿ REPORTED.

    Description of Event or Problem · 1

    "THE EDGE OF THE FIBER BROKE DURING THE SURGERY AND ITS USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572546 SUREFLEX FIBERS POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) S-LLF273TG 409A

    Patients

    Seq Age Sex Outcome Treatment
    1