BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSFLOW CONSOLE

    MDR report key: 4242736 · Received November 11, 2014

    Report

    Report Number
    0002936485-2014-00899
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 21, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K123441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 NOT CONFIRMED. VISUAL INSPECTION : NO PHYSICAL DAMAGES SEEN ON THE UNIT. FUNCTIONAL INSPECTION : THE PUMP BOOTED UP AND THE CRITICAL ERROR LOG WAS ALSO REVIEWED AND THERE WERE NO ERRORS RELATED TO THE COMPLAINT. AN INFLOW/OUTFLOW CASSETTE TUBE SET WAS INSERTED INTO THE PUMP AND CONNECTED WITH A CROSSFIRE CONSOLE USING A FIREWIRE CABLE. THE CROSSFIRE HAD A FOOTSWITCH, SHAVER, AND RF PROBE CONNECTED. THE CROSSFLOW TUBE SETS WERE CONNECTED TO A WATER SOURCE AND JOINT TEST FIXTURE THAT INCLUDED A PRESSURE SENSOR TRANSDUCER. THE UNIT WAS THEN RUN. FOR EACH PRESSURE SETTING, PRESSURE WAS APPLIED TO THE JOINT TEST FIXTURE MEMBRANE AND A SHAVER AND RF PROBE WERE ACTIVATED. THE TESTING CONFIRMED THAT THE PUMP WAS ABLE TO RECOVER AND THEN MAINTAIN THE SET PRESSURES WITHIN +/- 15MM HG DURING MEMBRANE DEPRESSIONS AND HANDPIECE ACTIVATIONS. NO ISSUES OBSERVED DURING TESTING. THE CUSTOMERS COMPLAINT OF EXTRAVASATIONS WAS NOT DUPLICATED. HOWEVER, IT WAS MENTION IN THE ORACLE THAT THE PUMP - "WON'T ACCEPT CUSTOMIZATION SETTINGS:¿ AN E26 ERROR KEEPS ON BEING DISPLAYED DURING PROFILE SELECTION SPECIFICALLY ON BLACKMON AND PALOMINO PROFILES. THIS ISSUE IS LIKELY DUE TO 1) SURGEON TECHNIQUE INCLUDING INCISION SIZES AND PROCEDURE TIME, 2) VARIATIONS IN SCOPE OR CANNULA SIZE OR CONDITION, OR 3) SOFTWARE ERROR. IN SUM, THE PRODUCT WAS RETURNED, BUT THE FAILURE MODE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS EXTRAVASATION WHILE THE DEVICE WAS BEING USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS EXTRAVASATION WHILE THE DEVICE WAS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726013 CROSSFLOW CONSOLE ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1