BEUDAMED
    FDA Adverse Event Summary report: N

    STRYKER X8000

    MDR report key: 1031858 · Received April 7, 2008

    Report

    Report Number
    1031858
    Date Received
    April 7, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 7, 2008
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCT
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    NO INJURY OR INCIDENT WITH ANY PATIENTS. THE SCRUB TECH NOTED THAT THE END OF THE LAPAROSCOPE, WHEN CONNECTED TO THE STRYKER LIGHT SOURCE, SEEMED TO BECOME EXTREMELY HOT VERY QUICKLY. AFTER CASES WERE COMPLETED, WE TESTED THE LIGHT SOURCE AND SCOPE WITH A GOWN. THE LIGHT SOURCE WAS SET AT 90 AND TURNED ON WITH THE END OF THE SCOPE ON A GOWN. WE FOUND THAT THIS MADE A HOLE IN THE GOWN IN 10 TO 15 SECONDS. WE FOUND THIS ALARMING, AND CONTACTED THE MANUFACTURER'S REPRESENTATIVE. THE REPRESENTATIVE CAME TO THE HOSPITAL, AND WE DEMONSTRATED THIS TO HIM. HE STATED THAT HE WAS AWARE OF ISSUES WITH THE END OF THE LIGHT CORD BECOMING HOT, BUT STATED THAT HE WAS NOT AWARE OF AN ISSUE WITH THE END OF THE SCOPE ALSO BECOMING HOT. HE FURTHER STATED THAT THE LIGHT SOURCE SHOULD NEVER BE SET ABOVE 50, DUE TO CAUSING INCREASED HEAT. WE TESTED THE SAME LIGHT SOURCE, CORD, AND SCOPE WITH THE UNIT SET AT 50 AND AFTER 2 MINUTES THERE WAS NO HOLE OR DAMAGE TO THE GOWN. NOTE THAT THE LIGHT SOURCES WERE SET TO 90 UPON INSTALLATION AND HAD NOT BEEN ADJUSTED DOWN SINCE WE HAD NO IDEA THAT THIS WAS AN ISSUE OR THAT THE UNIT SHOULD NOT BE SET ABOVE 50 PER THE REP. WE WOULD LIKE MANUFACTURER GUIDELINES ON THIS MADE AVAILABLE IF POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER X8000 LIGHT SOURCE, SURGICAL GCT STRYKER ENDOSCOPY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *