BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X7000 XENON LIGHTSOURCE

    MDR report key: 1903575 · Received November 15, 2010

    Report

    Report Number
    2936485-2010-00844
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 28, 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 WAS 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 FAILED TO IGNITE. THE POWER-UP SEQUENCE WAS REPEATED MULTIPLE TIMES. THE BULB FAILED TO IGNITE AFTER EACH CYCLE. AN EVALUATION WAS CONDUCTED ON THE ABILITY OF THE JAW AND THE LIGHTCABLE TO ENGAGE. THE EVALUATION WAS SUCCESSFUL. A MEASUREMENT WAS TAKEN ON THE BOOST VOLTAGE. THE RESULTING MEASUREMENT WAS 0 VOLTS, WHICH IS CLEARLY OUT OF SPECIFICATION. THE ROOT CAUSE OF THE REPORTED FAILURE WAS TRACED TO A DEFECTIVE BALLAST. 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 PRODUCT CAME OFF STANDBY AND WAS NOT RUNNING. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X7000 XENON LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 04G006414

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK