BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2193047 · Received August 5, 2011

    Report

    Report Number
    2955842-2011-00254
    Event Type
    Other
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K011002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY AN ISI FIELD SERVICE ENGINEER FOUND THAT THE CONSOLE VISION CABLE WAS DEFECTIVE AND DIFFICULT TO INSERT INTO THE VISION SIDE CART. THE CONSOLE VISION CABLE CONNECTS THE VISION CART TO THE SURGEON SIDE CONSOLE (SSC) AND PASSES THE VIDEO SIGNALS BETWEEN THE SSC AND THE VISION CART. THE SYSTEM WAS REPAIRED BY REPLACING THE CONSOLE VISION CABLE. AS OF (B)(4) 2011 THERE HAVE BEEN NO REPORTED RECURRENCES OF THIS ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING TO START A DA VINCI S PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED LOSS OF VIDEO IN THE LEFT EYE OF THE HIGH RESOLUTION STEREO VIEWER. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE), THE SITE RESTARTED THE CAMERA CONTROLLER UNIT (CCU) AND THE VISION WAS RESTORED TO NORMAL. APPROXIMATELY 4 HOURS LATER, THE SITE CALLED BACK STATING THAT THE RIGHT EYE OF THE HIGH RESOLUTION STEREO VIEWER APPEARED DISTORTED. THE TSE DISCOVERED THAT THE SITE HAD REVERSED THE CCU CABLE CONNECTIONS. THE SITE UNPLUGGED AND RESEATED THE CCU CONNECTION AND THE IMAGE APPEARED NORMAL. THE TSE THEN CONTINUED TO ASSIST THE SITE WITH THE VISION SET UP AND FOUND THE HRSV LEFT EYE BECOME BLACK. THE PATIENT WAS UNDER ANESTHESIA FOR APPROXIMATELY 2 HOURS AND THE PORT INCISIONS WERE MADE WHEN THE SURGEON DECIDED TO ABORT 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 SYSTEM, INSTRUMENTS AND ACCESSORIES