BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 2141336 · Received June 1, 2011

    Report

    Report Number
    2936485-2011-00385
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION WITHOUT THE BULB INSTALLED. ALL TESTING WAS CONDUCTED USING A KNOWN GOOD TEST BULB. THE REPORTED FAILURE WAS 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 BECAME ACTIVE, AND THE CORRECT SOFTWARE LOADED. THE PRODUCT WENT INTO STANDBY MODE 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. THE LIGHTCABLE/JAW INTERACTION TEST FAILED DUE TO THE JAW NOT LOCKING IN THE OPEN POSITION. ALL OTHER TESTS WERE SUCCESSFUL. THE ROOT CAUSE OF THE REPORTED FAILURE WAS TRACED TO A DEFECTIVE JAW ASSEMBLY. FURTHER INVESTIGATION REVEALED THAT THE RUN MEMBRANE SWITCH HAD A COLLAPSED DOME. IN SUM, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE JAW ON THE UNIT WAS HAVING ISSUES WHICH IN TURN CAUSED ERRORS TO THE SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK