BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOSTEADY - ARTHROSCOPY POLE PUMP

    MDR report key: 3900688 · Received June 27, 2014

    Report

    Report Number
    0002936485-2014-00433
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K030402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: PRESSURE SENSOR MALFUNCTION/OUT OF CALIBRATION. INFLOW CASSETTE/ TUBING PRESSURE SENSOR MEMBRANE FAILURE. MIS-INSERTED CASSETTE/ TUBING. MOTOR ENCODER MALFUNCTION/FAILURE (INFLOW AND/OR OUTFLOW). ROLLER WHEEL ASSEMBLY (INFLOW AND/OR OUTFLOW) MALFUNCTION/FAILURE. ROLLER WHEEL FAILURE DUE TO PERISTALTIC TUBING DEBRIS BUILD-UP. MAIN BOARD (ALL) /IMX FAILURE. SOFTWARE MALFUNCTION. USE ERROR. SYSTEM DESIGN. UNWANTED MOVEMENT OF INTERNAL COMPONENTS/WIRING. PRESSURE SENSOR IS OPERATED ABOVE LINEAR PRESSURE READING RANGE. PUMP OPERATED AT LEAST-FAVORABLE ENVIRONMENTAL CONDITIONS FOR EXTENDED PERIOD OF TIME. RUN SCREEN DOES NOT ADEQUATELY INDICATE OVERPRESSURE SITUATION. MINIWASH MALFUNCTION. COMMAND NOT REGISTERED FROM HAND CONTROL, FOOTSWITCH , SIDNE OR HERMES. EXCESSIVE USE OF WASH OR TURBO. SLOW REACTION TIME TO A QUICKLY CLOSED OFF SHAVER OUTFLOW AT HIGH FLOW RATES. POWER FAILURE OF PUMP. PRESSURE SENSOR STUCK BEHIND THE SENSOR BRACKET. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASE CRACKED AND THE HIGH PRESSURE WOULD NOT DECREASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASE CRACKED AND THE HIGH PRESSURE WOULD NOT DECREASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377711 FLOSTEADY - ARTHROSCOPY POLE PUMP ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1