BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 1813091 · Received August 18, 2010

    Report

    Report Number
    2936485-2010-00640
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 WAS ACTIVATED, AND THE CORRECT SOFTWARE LOADED. STANDBY MODE BECAME ACTIVE AND 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: STANDBY/RUN MODE CYCLING; VARIABILITY OF LIGHT INTENSITY; LIGHTCABLE/SCOPE DISCONNECT; LIGHTCABLE/JAW INTERACTION; BULB ACCESS DOOR CYCLING; FRONT PANEL. NO ISSUES WERE NOTED. THE PRODUCT WAS SUBJECTED TO BURN-IN TESTING. NO FAILURES OCCURRED. MEASUREMENT WERE TAKEN ON LUMEN OUTPUT AND BULB VOLTAGE. BOTH MEASUREMENTS WERE WITHIN THEIR RESPECTIVE SPECIFICATIONS. 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 WILL NOT COME OFF STANDBY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 07L010544

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK