BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 1881267 · Received October 18, 2010

    Report

    Report Number
    2936485-2010-00773
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE WAS PARTIALLY CONFIRMED AS THE E-3 ERROR WAS DUPLICATED. THE E-1 ERROR COULD NOT BE DUPLICATED. 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. AN E-3 ERROR MESSAGE APPEARED ON THE DISPLAY. THE POWER-UP SEQUENCE WAS REPEATED SEVERAL TIMES. AN E-3 ERROR MESSAGE APPEARED AFTER EACH CYCLE. 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. THE VARIABILITY OF LIGHT INTENSITY TEST FAILED. ALL OTHER TESTS WERE SUCCESSFUL. A MEASUREMENT WAS TAKEN ON THE BULB VOLTAGE. THE MEASUREMENT WAS BELOW THE LOWER SPEC LIMIT. THE BULB FROM THE PRODUCT WAS REPLACED WITH A KNOWN GOOD TEST BULB AND THE POWER-UP SEQUENCE WAS REPEATED. NO E-3 ERROR MESSAGES WERE DISPLAYED. THE ROOT CAUSE OF THE REPORTED FAILURE WAS TRACED TO A DEFECTIVE BULB. IN SUM, THE CUSTOMER COMPLAINT WAS PARTIALLY CONFIRMED FOR THE E-3 ERROR ONLY. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT EXPERIENCED BOTH AN E-1 AND E-3 ERROR.

    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