BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHT SOURCE

    MDR report key: 3143598 · Received June 3, 2013

    Report

    Report Number
    0002936485-2013-00247
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FCW
    PMA / PMN Number
    K082813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. COSMETIC INSPECTION CONFIRMED THERE WERE NO OUTWARD SIGNS OF DAMAGE AND ALSO NO LOOSE PARTS/ITEMS. INITIAL POWER SEQUENCE INCLUDED: POWERING UP; CONFIRMING DISPLAY ACTIVITY; LOADING CORRECT SOFTWARE; STANDBY MODE CHECK; LED LIGHT OUTPUT; ERROR CODE CHECK; REPEATING SEQUENCE SEVERAL TIMES. ALL SEQUENCE TESTS REPEATEDLY PASSED WITH NO ERROR CODES BEING POSTED. FUNCTIONALITY TESTING INCLUDED: STANDBY/RUN MODE CYCLING; VARIABILITY OF LIGHT INTENSITY; ESST/SAFELIGHT SCOPE DISCONNECT; SAFELIGHT/069 CABLE SHAKE; LIGHTCABLE/JAW INTERACTION; FRONT PANEL CONTROLS. ALL FUNCTIONALITY TESTS PASSED. MEASUREMENTS WERE TAKEN ON THE LUMEN OUTPUT AND CHROMATICITY, BOTH WITHIN SPECIFICATION VALUES. THE LOGFILE WAS REVIEWED, NO ERRORS FOUND. BURN-IN TEST: TWO HOURS OF CONSTANT AND POWER CYCLE DID NOT PRODUCE ANY ERRORS OR FAILURES. HOWEVER, PREVIOUS COMPLAINTS OF THIS NATURE WERE FOUND TO BE CAUSED BY LINT BUILDUP ON THE BEAM SENSOR OR POSSIBLY A LOOSE ELECTRICAL CONNECTION OF THE ESST CIRCUIT. INSPECTION REVEALED THAT THE ESST SCREW WAS LOOSE AND MAKING PARTIAL CONTACT; THIS ISSUE CAN CAUSE UNSTABLE LIGHT OUTPUT. DURING USAGE THERE IS THE POSSIBILITY THAT THE SCREW BECAME LOOSE FROM EXCESSIVE MOVEMENT OF THE LIGHT CABLE INSIDE THE JAW ASSEMBLY. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION BUT THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT TURNS ON AND OFF AUTOMATICALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT TURNS ON AND OFF AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244584 L9000 LIGHT SOURCE LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1