BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOCONTROL ARTHROSCOPY PUMP (HAND CONTROL INCLUDED)

    MDR report key: 3242678 · Received July 23, 2013

    Report

    Report Number
    0002936485-2013-00304
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K030402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. 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 WITH PRESSURE SENSOR TRANSDUCER CONNECTED. THEN THE PUMP WAS ALLOWED TO RUN FOR SEVERAL MINUTES AND WAS ABLE TO MAINTAIN THE CORRECT OPERATING PRESSURE WHEN SET AT A PRESSURE OF 50 MM HG WITH A LARGE AMOUNT OF OUTFLOW FROM THE JOINT AND TESTED AT DIFFERENT FLOW RATES. HOWEVER WITH NO JOINT OUTFLOW, OVERPRESSURE OCCURRED. THE PUMP WAS OPENED TO SEE IF THERE WERE ANY DAMAGED COMPONENTS; NONE WERE SEEN. THE ERROR LOG WAS REVIEWED AND INDICATED THAT THE ROLLER WHEELS ARE WORN OUT AND NEED TO BE REPLACED. DUE TO THIS THERE WERE SEVERAL MOTOR ERROR MESSAGES IN THE LOG. THE INFLOW MOTOR WAS REPLACE AND PUMP WAS RECALIBRATED. THE PUMP WAS RETESTED AND WAS ABLE TO MAINTAIN THE CORRECT OPERATING PRESSURE. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE COULD BE THE INFLOW MOTOR ERROR AND WORN OUT ROLLER WHEELS. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP'S PRESSURE WAS OFF AND THAT IT WAS PUMPING TOO FAST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP'S PRESSURE WAS OFF AND THAT IT WAS PUMPING TOO FAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342582 FLOCONTROL ARTHROSCOPY PUMP (HAND CONTROL INCLUDED) ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1