BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOPHY MINI VALVE

    MDR report key: 5569740 · Received November 24, 2015

    Report

    Report Number
    3001587388-2015-15385
    Event Type
    Injury
    Date Received
    November 24, 2015
    Report Date
    November 10, 2015
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    PMA / PMN Number
    K013488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL NATURE OF THE EVENT CAUSING THE DOCTOR TO EXPLANT THE DEVICE IS NOT CLEAR AT THIS MOMENT. WAITING THE RETURNED PLACE TO CONFIRM THE DEFAULT.

    Additional Manufacturer Narrative · 1

    SOPHYSA HAS RECEIVED THE RETURNED PIECE AND THE PRODUCT IN QUESTION HAS BEEN EXAMINED ACCORDING TO OUR QUALITY CONTROL PROCEDURE: VISUAL CHECK: COLORLESS LIQUID IS VISIBLE IN THE VALVE AND THE RESERVOIR, DEPOSITS ARE PRESENT NEAR THE RUBY BALL AND ON THE SPRING OF THE ROTOR. THE RESERVOIR IS CLEAN. THE SIGHT SHOWS THAT THE INLET CONNECTOR IS RELEASED OF THE VALVE THEREFORE ALL CALIBRATED PRESSURES HAVE BEEN CHANGED. FUNCTIONAL CONTROL: THE VALVE IS NOT STUCK AND COULD BE PROGRAMMED CORRECTLY WITHOUT DIFFICULTY. PRESSURE CONTROL: PRESSURE CONTROL IS NOT POSSIBLE AS THE INLET CONNECTOR IS RELEASED OF THE VALVE, INVALIDING ALL THE CALIBRATED PRESSURE. THE ROOT CAUSE OF THE VALVE DEFAULT IS THE DISPLACEMENT OF THE INLET CONNECTOR. THE VALVE IS 100% CONTROLLED (PRESSURE/FLOW CHARACTERISTICS, VISUAL CONTROLS, ETC.) DURING THE MANUFACTURING PROCESS. THE PRESSURE SETTING IS PRE-CALIBRATED AND IS DIRECTLY RELATED TO THE CALIBRATED POSITION OF THE INLET CONNECTOR. THE DISPLACEMENT OF THE INLET CONNECTOR COULD NOT HAVE BEEN ORIGINATED FROM THE MANUFACTURING PROCESS. IN SOPHYSA RECORD, THE DISPLACEMENT OF THE INLET CONNECTOR HAS NEVER HAPPENED IN THE NORMAL USE CONDITION. SPONTANEOUS DISPLACEMENT OF THE INLET CONNECTOR IS NOT QUITE POSSIBLE TO OUR KNOWLEDGE. THE CAUSE OF THE DISPLACEMENT OF THE INLET CONNECTOR COULD NOT BE IDENTIFIED IN LABORATORY CONDITION.

    Description of Event or Problem · 1

    THE DOCTOR EXPLANTED THE DEVICE AS IT IS NO LONGER FUNCTIONING.

    Description of Event or Problem · 1

    THE DOCTOR EXPLANTED THE DEVICE AS IT IS NO LONGER FUNCTIONING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779085 SOPHY MINI VALVE ADJUSTABLE HYDROCEPHLUS VALVE JXG SOPHYSA SM8A + BO19-10 + B905-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other