BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2386433 · Received December 22, 2011

    Report

    Report Number
    2955842-2011-00414
    Event Type
    Other
    Date Received
    December 22, 2011
    Date of Event
    November 22, 2011
    Report Date
    November 22, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER DETERMINED THAT THE VISION ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE VIDEO DIGITIZER. THE DIGITIZER CONVERTS THE ANALOG VIDEO IMAGES RECORDED BY THE CAMERA INTO A DIGITAL FORMAT SO THAT IT CAN BE TRANSMITTED OVER THE FIBER-OPTIC CABLE AND COMBINED WITH OTHER IMAGES (SUCH AS THE USER INTERFACE ICONS AND TEXT OR AN AUXILLIARY IMAGE FROM AN ULTRASOUND OR OTHER SOURCE). THE SYSTEM WAS REPAIRED BY REPLACING THE VIDEO DIGITIZER. THE DIGITIZER WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS PERFORMED AND ENGINEERING WAS UNABLE TO REPLICATE THE REPORTED FAILURE MODE. AS OF DECEMBER 20, 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S NEPHRECTOMY PROCEDURE, VISION WAS LOST ON THE TOUCHSCREEN AND SLAVE MONITORS WHEN A SURGICAL STAFF MEMBER TRIPPED OVER THE POWER CORD CONNECTED TO THE VISION CART. WITH THE ASSISTANCE OF AN INTUITIVE SURGICAL TECHNICAL SUPPORT ENGINEER, THE SITE ATTEMPTED TO TROUBLESHOOT THE ISSUE BY VERIFYING THAT THE POWER CORDS WERE FULLY SEATED AND THEN POWER CYCLING THE VISION CART MULTIPLE TIMES. THESE ACTIONS WERE UNABLE TO RESOLVE THE ISSUE AND THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S INSTRUMENTS AND ACCESSORIES