BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1781816 · Received August 3, 2010

    Report

    Report Number
    2955842-2010-00351
    Event Type
    Other
    Date Received
    August 3, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 5, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY ISI FIELD ENGINEERING DISCOVERED THAT THE LEFT CAMERA INPUT CABLE WAS CONNECTED TO THE RIGHT CAMERA CONTROLLER UNIT (CCU) AND THE RIGHT CAMERA INPUT CABLE WAS CONNECTED TO THE LEFT CCU, THUS CAUSING THE CUSTOMER REPORTED VISION ISSUE. THE CAMERA CABLES CONNECT THE CAMERA TO THE CCU. THE CCU THEN CALIBRATES AND ADJUSTS THE BRIGHTNESS LEVELS OF THE VIDEO IMAGE FROM THE TWO HIGH MAGNIFICATION CAMERA HEADS. THE CCU FEEDS THE IMAGE THROUGH THE VIDEO SYNCHRONIZER TO THE SURGEON'S CONSOLE AND ASSISTANT MONITOR. THE SYSTEM WAS REPAIRED BY RECONNECTING THE CAMERA CABLES INTO THE CORRECT CCU INPUT PORTS. THE ISI FIELD ENGINEER MADE THE SURGEON AWARE OF THE ISSUE AND PROVIDED TRAINING ON PROPER INSTALLATION OD THE CAMERA CABLES. AS OF (B)(4) 2010, 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 SURGICAL PROCEDURE, THE SITE EXPERIENCED A POOR 3D IMAGE AND NON INTUITIVE MOVEMENT OF THE CAMERA ARM. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE SITE TRIED A REPLACEMENT ENDOSCOPE AND RECALIBRATED THE 3D IMAGE; HOWEVER, THE POOR IMAGE CONTINUED TO PERSIST. THE SURGEON DID NOT WANT TO CONTINUE TO TROUBLESHOOT AND DID NOT WANT TO PERFORM THE PROCEDURE IN 2D VISION AND DECIDED TO CONVERT THE PLANNED PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY 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