BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSFLOW CONSOLE

    MDR report key: 5086394 · Received September 17, 2015

    Report

    Report Number
    0002936485-2015-00833
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 25, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K123441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE

    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. 6ROLLER WHEEL FAILURE DUE TO PERISTALTIC TUBING DEBRIS BUILD-UP. MAIN BOARD (ALL) /IMX FAILURE (CF). SOFTWARE MALFUNCTION (1, 3, 3.1, 3.4, 3.15, 3.16, 3.17, 4,, 8 FOR CF, OR RELATED MODULES IN OTHER PUMPS). USE ERROR. SYSTEM DESIGN. UNWANTED MOVEMENT OF INTERNAL COMPONENTS/WIRING. PRESSURE SENSOR IS OPERATED ABOVE LINEAR PRESSURE READING RANGE (>450 MMHG FOR CF) (DESIGN). PUMP OPERATED AT LEAST-FAVORABLE ENVIRONMENTAL CONDITIONS FOR EXTENDED PERIOD OF TIME. RUN SCREEN DOES NOT ADEQUATELY INDICATE OVERPRESSURE SITUATION. MINIWASH MALFUNCTION (CF). COMMAND NOT REGISTERED FROM HAND CONTROL (ALL), FOOTSWITCH (CF), (B)(4) (FC, AP) OR (B)(4) ((B)(4) READY). 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. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CROSSFLOW SHOWED THE CURRENT PRESSURE OF 250MMHG DURING RUNNING BUT THE DISPLAY WAS FLASHING. THERE WAS OVER-PRESSURE OBSERVED IN THE JOINT. HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION OR SURGICAL DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CROSSFLOW SHOWED THE CURRENT PRESSURE OF 250MMHG DURING RUNNING BUT THE DISPLAY WAS FLASHING. THERE WAS OVER-PRESSURE OBSERVED IN THE JOINT. HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614916 CROSSFLOW CONSOLE ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1