BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 2894617 · Received December 10, 2008

    Report

    Report Number
    1825014-2008-00011
    Event Type
    Malfunction
    Date Received
    December 10, 2008
    Date of Event
    October 27, 2008
    Report Date
    December 8, 2008
    Manufacturer
    MIZUHO MEDICAL CO LTD
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY RECEIVED REPORTS THAT SOME EXTREME POSITIONING / ARTICULATION MANEUVERS INITIATED DURING DAVINCI ROBOTIC PROCEDURES CAN POSSIBLY RESULT IN THE BACK SECTION COLLIDING WITH THE BASE OF THE 3600B TABLE. THIS EXTREME ARTICULATION CAN RESULT IN THE BACK SECTION BECOMING UNLOCKED. SECTIONS OF THE TABLE CAN CONFLICT WITH EACH OTHER; HOWEVER, IN THIS CASE SEVERAL STEPS ARE REQUIRED TO REPLICATE THE DISENGAGEMENT OF THE BACK SECTION. TO OUTLINE THIS EVENT, THE PT IS BEING PLACED IN A LITHOTOMY POSITION AND THE 3600B ARTICULATED INTO MAXIMUM TRENDELENBURG. WITH THE HEAD SECTION REMOVED, SOME SLIGHT BACK DOWN ADDED AND THE TABLE LONGITUDINAL MOTION ACTUATED TOWARD THE FOOT, THE RESULTING RATHER COMPLEX SERIES OF ARTICULATIONS AND MOVEMENTS IS AN UNLOCKING OF THE BACK SECTION. THE PROCEDURES REQUIRING THIS POSITION IS ARE DAVINCI PROSTATECTOMY AND HYSTERECTOMY CASES. THIS EVENT WAS NOT EASY TO REPRODUCE BUT WAS ACCOMPLISHED AND IS CURRENTLY BEING STUDIED. WE ARE RECOMMENDING THAT THOSE ACCOUNTS USING THE 3600B WITH THESE POSITIONAL REQUIREMENTS REVIEW THE 3600B OPERATOR'S MANUAL AND PRECAUTIONS OUTLINE IN THE SPECIAL USER ATTENTION SECTIONS.

    Description of Event or Problem · 1

    DURING A DAVINCI ROBOTIC PROCEDURE AT (B)(6), THE 3600B SURGICAL TABLE WAS POSITIONED AS FOLLOWS: TRENDELENBURG ARTICULATION WAS DEPLOYED AT THE FULL 30 DEGREES OF HEAD DOWN, THE TABLE TOP SLIDE INITIATED TOWARD THE PT'S HEAD AND THE BACK DOWN FUNCTION ENGAGED SLIGHTLY, PRODUCING A DIRECT CONTACT POINT WITH THE TABLE BASE TOP COVER CORNERS AND THE BACK SECTION RELEASE LEVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON SURGICAL TABLE GDC MIZUHO MEDICAL CO LTD 3600B

    Patients

    Seq Age Sex Outcome Treatment
    1