BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHTSOURCE

    MDR report key: 2053381 · Received March 16, 2011

    Report

    Report Number
    2936485-2011-00162
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, AND THE CORRECT SOFTWARE LOADED. STANDBY MODE BECAME ACTIVE AND THE LED FUNCTIONED AS SPECIFIED. 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; LIGHT CABLE/SCOPE DISCONNECT; LIGHT CABLE SHAKE; LIGHT CABLE/JAW INTERACTION; FRONT PANEL. ALL 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 SPECS. THE LOG FILE 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 WENT TO STANDBY DURING A CASE. IT WAS FURTHER REPORTED THERE WAS NO HARM TO THE PT.

    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