BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSFLOW CONSOLE

    MDR report key: 4090707 · Received September 15, 2014

    Report

    Report Number
    0002936485-2014-00726
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 27, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    MBI
    PMA / PMN Number
    K123441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    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 WITH THE FOLLOWING SOFTWARE VERSION: 01.02.05. 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 AND 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 WAS NOT DUPLICATED. HOWEVER, IT IS RECOMMENDED TO HAVE THE SOFTWARE UPDATED. PROBABLE ROOT CAUSES COULD BE (1) USER ERROR (2) SOFTWARE ERROR (3) STUCK PRESSURE SENSOR 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 THE UNIT HAD TO BE SWITCHED OFF DUE TO OVER-INFLATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD TO BE SWITCHED OFF DUE TO OVER-INFLATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570162 CROSSFLOW CONSOLE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1