BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHTSOURCE

    MDR report key: 2082047 · Received April 26, 2011

    Report

    Report Number
    2936485-2011-00257
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE PRODUCT WAS SUBJECTED TO A SHAKE TEST TO SEE IF THERE WERE ANY LOOSE COMPONENTS INSIDE. THERE WERE NONE. THE PRODUCT WAS POWERED UP, THE DISPLAY ACTIVATED, THE CORRECT SOFTWARE LOADED, AND STANDBY MODE BECAME ACTIVE. THE POWER-UP SEQUENCE WAS REPEATED SEVERAL TIMES. NO ISSUES WERE NOTED. FUNCTIONAL TESTING WAS PERFORMED ON THE PRODUCT AND INCLUDED THE FOLLOWING: STANDBY/RUN MODE CYCLING; VARIABILITY OF LIGHT INTENSITY; LIGHTCABLE/SCOPE DISCONNECT; LIGHTCABLE/JAW INTERACTION; FRONT PANEL. THE LIGHTCABLE/JAW INTERACTION TEST FAILED DUE TO A LOOSE JAW HANDLE. ALL OTHER TESTS WERE SUCCESSFUL. THE PRODUCT WAS SUBJECTED TO BURN-IN TESTING. NO FAILURES OCCURRED. MEASUREMENTS WERE TAKEN ON LUMEN OUTPUT AND CHROMATICITY. BOTH MEASUREMENTS WERE WITHIN THEIR RESPECTIVE SPECIFICATIONS. THE LOGFILE WAS REVIEWED FOR ERROR HISTORY. NO ERRORS WERE NOTED. IN SUM, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT EXPERIENCED AN E-2 ERROR. IT WAS FURTHER REPORTED THAT THE UNIT EXPERIENCED OFF COLOR LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L9000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK