BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSFLOW CONSOLE

    MDR report key: 4252337 · Received November 14, 2014

    Report

    Report Number
    0002936485-2014-00923
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    November 5, 2014
    Report Date
    November 7, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K123441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    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. FROM THE EVENT DESCRIPTION AND INFORMATION OBTAINED FROM THE CROSSFLOW PUMP¿S LOG, IT APPEARS THE PUMP¿S SUCTION SETTINGS WERE MANUALLY INCREASED TO 100% DURING THE PROCEDURE FOR AN EXTENDED PERIOD OF TIME, POSSIBLY TO COMPENSATE FOR THE LACK OF SUCTION FROM THE QUANTUM 2 RF PROBE. ELEVATED SUCTION LEVELS WILL ALSO INCREASE THE PUMP¿S INFLOW RATE. INCREASED INFLOW RATES FOR EXTENDED PERIODS OF TIME MAY LEAD TO SWELLING. AN INVESTIGATION WAS ALSO PERFORMED AS TO WHY THE SUCTION SETTINGS WERE INCORRECT ON THE USED PROFILE. IT WAS DISCOVERED THAT TWO PROFILES WITH THE SAME NAME BUT DIFFERENT LETTER CAPITALIZATIONS WERE USED ON THE SAME IPAD SOFTWARE PROGRAM (PROFILES NAMED "BLAKE" AND "BLAKE"). ALTHOUGH THE CROSSFLOW IPAD SOFTWARE AND THE CROSSFLOW PUMP SOFTWARE ARE ABLE TO DIFFERENTIATE FILENAME CAPITALIZATIONS, WINDOWS-FORMATTED USB DONGLES ARE NOT ABLE TO DIFFERENTIATE CAPITALIZATION AND WILL READ THESE FILENAMES AS THE SAME. BECAUSE OF THIS, IT IS POSSIBLE THAT A PROFILE INTENDED FOR YOUR FACILITY WAS OVER-WRITTEN ON THE USB BY A PROFILE INTENDED FOR ANOTHER FACILITY WITH DIFFERENT RF SUCTION SETTINGS, POTENTIALLY LEADING TO THE OBSERVED SUCTION ISSUE IN THE RF PROBE. THE CUSTOMERS COMPLAINT WAS NOT DUPLICATED, THOUGH FILE TRANSFER AND USER SETTINGS MAY HAVE CREATED THE ISSUE. NO PROBLEM FOUND. THE PROBABLE ROOT CAUSE BE (1) ERROR IN FILE TRANSFER OR (2) USER SETTINGS. IN SUM, THE PRODUCT WAS RETURNED, BUT 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 THE CASE WAS CONVERTED TO OPEN SURGERY DUE TO OVERPRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASE WAS CONVERTED TO OPEN SURGERY DUE TO OVERPRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738716 CROSSFLOW CONSOLE ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1