BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER

    MDR report key: 1783174 · Received July 29, 2010

    Report

    Report Number
    MW5016936
    Event Type
    Other
    Date Received
    July 29, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 29, 2010
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FCW
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UNIT GAVE E1 ERROR (SECONDARY UNIT). THIS UNIT WAS PULLED INTO THE CASE ON AN EMERGENT BASIS, DUE TO "E1" ERROR WITH OUR PRIMARY N8000 LIGHT SOURCE. THIS UNIT ALSO GAVE "EI" ERROR. STAFF CALLED TECH SUPPORT. TECH SUPPORT REP HAD RN TURN UNIT OFF/ON - STILL HAD E1 ERROR - THEN ADVISED TO REMOVE BULB HOLDER AND RESEAT THE BOX. WHEN THE BOX WAS TURNED ON AND THE "RUN" BUTTON WAS PRESSED, THE LIGHT SOURCE ILLUMINATED WITHOUT FURTHER DIFFICULTY. THIS COULD HAVE BEEN DISASTROUS AS PT WAS UNDER GENERAL ANESTHESIA, INCISIONS HAD BEEN MADE. PRIMARY AND SECONDARY LIGHT SOURCE FAILURES, IF NOT REMEDIED, WOULD HAVE RESULTED IN ABORTED PROCEDURE OR OPEN CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER LIGHT SOURCE FCW STRYKER ENDOSCOPY X8000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR