BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD FOUR PORT MANIFOLD (10/BOX)

    MDR report key: 4017034 · Received August 18, 2014

    Report

    Report Number
    0001811755-2014-02914
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CLOG OF THE MANIFOLD WAS CONFIRMED BY A MANUFACTURER FIELD REPAIR TECHNICIAN THROUGH VISUAL INSPECTION OF PHOTOGRAPHS PROVIDED BY THE USER FACILITY. THE MANIFOLD HAS THE POTENTIAL TO CLOG DUE TO THE DESIGN OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE MANIFOLD CLOGGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494626 STANDARD FOUR PORT MANIFOLD (10/BOX) APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1