BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X7000 XENON LIGHTSOURCE

    MDR report key: 1872726 · Received October 12, 2010

    Report

    Report Number
    2936485-2010-00761
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    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 OF THE PRODUCT GETTING HOT 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 BECAME ACTIVE, AND THE CORRECT SOFTWARE LOADED. THE PRODUCT WENT INTO STANDBY MODE. THE BULB IGNITED AS SPECIFIED. THE POWER-UP SEQUENCE WAS REPEATED MULTIPLE TIMES. NO FAILURES OCCURRED. 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. ALL TESTS WERE SUCCESSFUL EXPECT FOR THE LIGHTCABLE/JAW INTERACTION TEST. THIS TEST FAILED DUE TO THE LIGHT STAYING ON AFTER THE CABLE WAS RELEASED. THE LIGHT SHOULD TURN OFF. THE PRODUCT WAS SUBJECTED TO BURN-IN TESTING. THE PRODUCT FAILED AFTER AN HOUR DUE TO THE BULB TURNING OFF. MEASUREMENTS WERE TAKEN ON BOOST VOLTAGE AND LUMEN OUTPUT. BOTH MEASUREMENTS WERE WITHIN THEIR RESPECTIVE SPECIFICATIONS. FURTHER INVESTIGATION REVEALED THAT THE PRODUCT HAD A DEFECTIVE BALLAST. THIS CAUSED THE POWER FLUCTUATIONS NOTED DURING THE TESTING. OTHER ISSUES NOTED INCLUDE THE FOLLOWING: THE INTEGRATED ROD WAS CHIPPED; THE JAW MECHANISM WAS OUT OF ALIGNMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS GETTING TOO HOT. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X7000 XENON LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 04F013014

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK