BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 1953937 · Received December 16, 2010

    Report

    Report Number
    2936485-2010-00927
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DETERMINE 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 BULB IGNITED 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: RUN MODE/STANDBY CYCLING; VARIABILITY OF LIGHT INTENSITY; LIGHT CABLE/SCOPE DISCONNECT; LIGHT CABLE/JAW INTERACTION; BULB ACCESS DOOR CYCLING; FRONT PANEL. ALL TESTS WERE SUCCESSFUL. THE PRODUCT WAS SUBJECTED TO BURN-IN TESTING. NO FAILURES OCCURRED. MEASUREMENTS WERE TAKEN ON LUMEN OUTPUT AND BULB VOLTAGE. BOTH MEASUREMENTS WERE WITHIN THEIR RESPECTIVE SPECIFICATIONS. IN SUM, THE CUSTOMER COMPLAINT OF AN E-1 ERROR 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-1 ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 08E007064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK