BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOSTEADY - ARTHROSCOPY POLE PUMP

    MDR report key: 3831304 · Received May 24, 2014

    Report

    Report Number
    0002936485-2014-00361
    Event Type
    Malfunction
    Date Received
    May 24, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K030402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. VISUAL INSPECTION FOUND THAT THE DEVICE WAS WITHIN RECOMMENDED CALIBRATION TIMEFRAME. DINGS AND SCRATCHES ARE NOTICED THROUGHOUT THE BEZEL. WITH THE POWER CORD DISCONNECTED THE DEVICE WAS POWERED, THE ILLUMINATION OF THE DISPLAY WAS VERIFIED. VERIFIED THAT THE MAIN VOLTAGE LED LIGHT TURNS ON AFTER CONNECTING POWER CORD. A LATCH TEST WAS CONDUCTED BY INSERTING A FLOSTEADY DISPOSABLE CASSETTE. VERIFIED THAT THE CASSETTE INSERTS COMPLETELY, PUSHED IN AND REMOVED. THE CRITICAL OVERPRESSURE WARNINGS VISUALS AND SOUNDS WERE VERIFIED USING A HAND-PUMP AT 260 MMHG AND GREATER. A HAND PRESSURE GAGE WAS USED TO CHECK THE ACCURACY OF THE PUMP. THE PUMP READ ALL VALUES WITHIN +/-5MM HG OF THE SET VALUE. A TUBE SET CASSETTE WAS INSERTED INTO THE PUMP WITH A WATER SOURCE, SHAVER, AND A JOINT TEST FIXTURE WITH A PRESSURE SENSOR TRANSDUCER CONNECTED. THE PUMP WAS THEN TESTED WITH A SET PRESSURE OF 50 MM HG WITH A FLOW RATE OF 1.5 L/MIN. THE PUMP WAS ALLOWED TO RUN FOR SEVERAL MINUTES. AFTER SEVERAL MINUTES, THE PUMP DID NOT OVERPRESSURE, HOWEVER IT WAS UNABLE TO MAINTAIN A SET PRESSURE WITH THE SHAVER OUTFLOW VALVE SET ON OPEN, HALF WAY, AND ALL THE WAY CLOSED. THE PUMP WAS OPENED TO SEE IF ANY DAMAGES WERE PRESENT INTERNALLY, IT WAS NOTICED THE CHASSIS IS SEVERELY BENT. THE BENT CHASSIS HAD CAUSED THE MOTOR TO COME INTO CONTACT WITH THE UNI BOARD DAMAGING A RESISTOR. THE PROBABLE ROOT CAUSE FOR THE PUMP ACTING AGGRESSIVE COULD BE THE DAMAGED RESISTOR ON THE UNI BOARD. 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 THERE WAS SWELLING IN THE PATIENTS JOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS SWELLING IN THE PATIENTS JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309652 FLOSTEADY - ARTHROSCOPY POLE PUMP ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1