BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER

    MDR report key: 1211186 · Received October 10, 2008

    Report

    Report Number
    1211186
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    July 25, 2008
    Report Date
    October 10, 2008
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WHITE FIBER OPTIC LIGHT CABLE BEGAN TO FLASH. NOTED "HOT" ODOR COMING FROM STRYKER LIGHT SOURCE. REMOVED WHITE FIBER OPTIC CABLE FROM LIGHT SOURCE. STERILE CST STATED "IT SHOCKED ME". SURGEON CLOSED PATIENT'S ABDOMEN. NO APPARENT BURNS NOTED ON PT. SURGEON CHOSE NOT TO EXPLORE THE ABDOMEN. PT TAKEN TO PACU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER LIGHT SOURCE, SURGICAL GCJ STRYKER ENDOSCOPY X6000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR