BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 1416900 · Received July 16, 2009

    Report

    Report Number
    1315756-2009-00003
    Event Type
    Other
    Date Received
    July 16, 2009
    Date of Event
    May 26, 2009
    Report Date
    July 15, 2009
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INITIAL REPORTER, THERE WAS NO MALFUNCTION OF EQUIPMENT. THE LIGHT SOURCE HAD BEEN ON APPROXIMATELY 45 MINUTES AT 100% POWER. THEY HAD FINISHED ONE SIDE OF THE PT, AND THEN LAID THE RETRACTOR DOWN ON THE PT FOR APPROXIMATELY 10 MINUTES; LIGHT SOURCE STILL ON AT 100%. DURING THIS 10 MINUTE PERIOD IS WHEN THE BURN OCCURRED ON THE PT. THE POINT WHERE THE RETRACTOR AND LIGHT CORD CONNECT IS WHAT WAS HOT AND CAUSED THE BURN. INITIAL REPORTER STATES THAT ALL EQUIPMENT IS STILL IN USE, BUT NOT IN THE CONFIGURATION THAT CAUSED THE BURN. A DIFFERENT LIGHT SOURCE AND LIGHT CORD IS NOW USED WITH THE LIGHTED RETRACTOR. INITIAL REPORTER ALSO STATES THAT DUE TO USAGE, THE OR DOESN'T WANT TO GIVE UP THEIR EQUIPMENT WITHOUT SUITABLE REPLACEMENTS. USER FACILITY IS AWARE THAT ESI RECOMMENDS USING 150 WATT HALOGEN LIGHT SOURCES WITH OUR PRODUCTS AS STATED IN OUR LABELING, PRODUCT CATALOGS, AND WEBSITE. E-MAIL WAS SENT WITH A HYPERLINK TO OUR NOTIFICATION REGARDING THE USE OF XENON OR HIGH WATTAGE LIGHT SOURCES.

    Description of Event or Problem · 1

    ILLUMINATED RETRACTOR CONNECTED TO 300W XENON LIGHT SOURCE. PT RECEIVED THIRD DEGREE BURN FROM HOT RETRACTOR WHERE FIBER OPTIC CABLE CONNECTS TO RETRACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY FIBEROPTIC LIGHT SOURCE (DEVICE 3) FCW STRYKER ENDOSCOPY X6000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ESI FIBER OPTIC CABLE| ESI FIBER OPTIC RETRACTOR