BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 2110347 · Received April 25, 2011

    Report

    Report Number
    2936485-2011-00255
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 SEE IF THERE WERE ANY LOOSE COMPONENTS INSIDE. THERE WERE NONE. THE PRODUCT WAS POWERED UP, THE DISPLAY ACTIVATED, AND THE CORRECT SOFTWARE LOADED. STANDYBY MODE DID NOT ACTIVATE AND THE BULB FAILED TO IGNITE. AN E-1 ERROR WAS OBSERVED. AN EVALUATION WAS CONDUCTED ON THE ABILITY OF THE LIGHTCABLE AND JAW TO ENGAGE. THE EVALUATION WAS SUCCESSFUL. FURTHER INVESTIGATION REVEALED THAT THE ROOT CAUSE OF THE REPORTED FAILURE WAS TRACED TO A DEFECTIVE BALLAST. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO IMPROVE THE PERFORMANCE OF THE BALLAST AND TO MAKE THE OCCURRENCE OF E-1 ERRORS LESS LIKELY. 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 UNIT EXPERIENCED AN E-1 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