BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 3143599 · Received June 3, 2013

    Report

    Report Number
    0002936485-2013-00246
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 17, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FSS
    PMA / PMN Number
    K961971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. COSMETIC INSPECTION CONFIRMED NO OUTWARD SIGNS OF DAMAGE AND ALSO NO LOOSE PARTS/ITEMS. THE UNIT FAILED TO POWER UP, THEREFORE, FUNCTIONALITY TESTS COULD NOT BE PERFORMED. THE FUSES WERE BLOWN AND FURTHER INSPECTION OF THE BALLAST POWER SUPPLY REVEALED THAT BALLAST POWER CAPACITOR HAD RELEASED THE ELECTROLYTIC FLUID THROUGH THE PRESSURE RELEASE VENTS. THIS FAILURE DOES NOT ENDANGER THE USER BECAUSE THE CAPACITOR RELEASES THE PRESSURE BY DESIGN AND THE FUSES BLOW TO PROTECT THE UNIT. THIS FAILURE HAS OCCURRED IN THE PAST DUE TO A VERY OLD REVISION BALLAST. IN THIS CASE THE BALLAST WAS AN OLDER REVISION WHICH IS OVER 6 YEARS OLD. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REPRESENTATIVE THAT UPON GETTING POWER A SMALL EXPLOSION AND SMOKE CAME OUT OF THE UNIT. THIS TRIGGERED THE FIRE ALARM AFTER SEVERAL SECONDS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REPRESENTATIVE THAT UPON GETTING POWER A SMALL EXPLOSION AND SMOKE CAME OUT OF THE UNIT. THIS TRIGGERED THE FIRE ALARM AFTER SEVERAL SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244657 X8000 LIGHTSOURCE LIGHT, SURGICAL, FLOOR STANDING FSS STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1