BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOCONTROL ARTHROSCOPY PUMP (HAND CONTROL INCLUDED)

    MDR report key: 3221686 · Received July 11, 2013

    Report

    Report Number
    0002936485-2013-00290
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K030402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECIEPT OF THE UNIT OVER-PRESSURE WAS CONFIRMED. (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGAITON HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. VISUAL INSPECTION CONFIRMED THE WARRANTY SEAL IS BROKEN AND THE INFLOW ROLLER WHEEL IS DIRTY. THE STICKER ON THE BACK OF THE UNIT INDICATES CALIBRATION IS NOT OVERDUE. THE PUMP WAS POWERED ON AND CHECKED FOR ANY ERROR MESSAGES; NONE WERE SEEN. A HAND PRESSURE GAUGE WAS USED TO CHECK THE ACCURACY OF THE PUMP AND WAS WITHIN SPECIFICATION. A TUBE SET WAS INSERTED INTO THE PUMP WITH A WATER SOURCE, SHAVER, AND A JOINT TEST FIXTURE. THEN THE PUMP WAS ALLOWED TO RUN FOR SEVERAL MINUTES AND WAS NOT ABLE TO MAINTAIN THE CORRECT OPERATING PRESSURE WHEN SET AT A PRESSURE OF 50 MM HG WITH NO JOINT OUTFLOW AND A LARGE AMOUNT OF OUTFLOW FROM THE JOINT AND TESTED AT DIFFERENT FLOW RATES. OVERPRESSURE WAS OBSERVED. THE PUMP WAS OPENED TO SEE IF THERE WERE ANY DAMAGE COMPONENTS; NONE WERE SEEN. THE POSSIBLE ROOT CAUSES FOR OVERPRESSURE ARE LOWER SENSOR AND THE ROLLER WHEEL. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT KEPT RUNNING WITHOUT THE PRESSURE SENSOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT KEPT RUNNING WITHOUT THE PRESSURE SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319940 FLOCONTROL ARTHROSCOPY PUMP (HAND CONTROL INCLUDED) ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1