BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1405640 · Received June 18, 2009

    Report

    Report Number
    1405640
    Event Type
    Malfunction
    Date Received
    June 18, 2009
    Date of Event
    June 4, 2009
    Report Date
    June 5, 2009
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    LNK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    PROCEDURE - CYSTOLITHOPAXY WITH HOLMIUM LASER. 1000 MICRON FIBER(ACMI LOT# D2707S EXP 2010-07) WAS OPENED AND LASER BEAM HAD A CRISP CIRCLE- WHEN PLACED THROUGH THE 23FR CONTINUOUS FLOW CYSTOSCOPE, THE FIBER APPEARED TO BE CRACKED. THIS FIBER WAS REPLACED WITH ANOTHER 1000 (ACMI LOT# D2908S EXP 2011-07) AND THIS APPEARED TO HAVE A SLIGHT CRACK - IT FUNCTIONED WITHOUT ANY PROBLEMS. AFTER A SHORT TIME, THE TIP BROKE OFF. THE BEAM LOOKED FINE AND THE MD CONTINUED TO USE THIS FIBER. MD REQUESTED TO USE A 600- MICRON FIBER (ACMI LOT#C2808S EXP 2011-07). THIS FIBER APPEARED TO SHED ITS OUTER COATING OF THE FIBER ITSELF- NOT THE INSULATION. THIS FIBER WAS REPLACED WITH ANOTHER 600 FIBER AND THAT FIBER WAS USED FOR THE REMAINDER OF THE CASE.THE FIBER WAS PASSED THROUGH A COOK CHECK-FLO ADAPTOR THAT HAS AN ID OF <= 9.0 FR WHICH ACCOMODATES THE 1000 MICRON FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LASER FIBER, 1000 MICRON LNK GYRUS MEDICAL, INC. * LD2707S
    2 * LASER FIBER, 1000 MICRON LNK GYRUS MEDICAL, INC. * D2808S
    3 * LASER FIBER, 600 MICRON LNK GYRUS MEDICAL, INC. * C2808S

    Patients

    Seq Age Sex Outcome Treatment
    1 *