BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSTEADY - ARTHROSCOPY POLE PUMP

    MDR report key: 4090705 · Received September 15, 2014

    Report

    Report Number
    0002936485-2014-00725
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K030402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS NOT CONFIRMED. THE FLOSTEADY - ARTHROSCOPY POLE PUMP WAS INSPECTED AND THE CALIBRATION STICKER ON THE BOTTOM OF THE PUMP INDICATES IT IS OVERDUE FOR CALIBRATION. THE PUMP WAS POWERED ON AND CHECKED FOR ANY ERROR MESSAGES. NONE WERE SEEN. A CASSETTE TUBE SET WAS INSERTED INTO THE PUMP WITH A WATER SOURCE, SHAVER, AND A JOINT TEST FIXTURE WITH PRESSURE SENSOR TRANSDUCER CONNECTED. THE PUMP RAN FOR SEVERAL MINUTES AND WAS ABLE TO MAINTAIN PRESSURE OF 25MM HG WITH THE SHAVER OUTFLOW VALVE SET TO OPEN, HALF WAY, AND CLOSED. THE PUMP WAS OPENED TO SEE IF ANY DAMAGES WERE PRESENT INTERNALLY, NONE WERE SEEN. THE COMPLAINT WAS NOT REPRODUCED. THE PROBABLE ROOT CAUSES FOR THE EVENT DESCRIPTION COULD BE CALIBRATION, PUMP HEIGHT, JOINT HEIGHT, THE STOP COCK VALVES WERE CLOSED OFF, SUCTION WAS CLOSED, OR TUBING WAS KINKED. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTRAVASATION OF THE SHOULDER REQUIRED MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTRAVASATION OF THE SHOULDER REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569793 FLOSTEADY - ARTHROSCOPY POLE PUMP ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1