BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURIGCAL SYSTEM

    MDR report key: 2190788 · Received August 4, 2011

    Report

    Report Number
    2955842-2011-00252
    Event Type
    Other
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K011005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY ISI FIELD SERVICE ENGINEERING CONCLUDED THAT THE ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE CAMERA HEAD. THE CAMERA PRODUCES A THREE DIMENSIONAL IMAGE TO THE VISION SYSTEM THROUGH RIGHT AND LEFT OPTICAL PATHS. THE IMAGES ARE THEN ACQUIRED THROUGH SEPARATE OPTICAL CHANNELS OF THE ENDOSCOPE AND ARE DIRECTED TO THE CAMERA HEAD AND PROCESSED INDEPENDENTLY. THE DA VINCI S SURGICAL SYSTEM USER'S MANUAL EXPLICITLY STATES THAT: ENVIRONMENTAL OR EQUIPMENT FAILURES MAY CAUSE THE DA VINCI S SYSTEM TO BECOME UNAVAILABLE. THE SURGICAL TEAM SHOULD ALWAYS HAVE BACK UP EQUIPMENT AND INSTRUMENTATION AVAILABLE, AND BE PREPARED TO CONVERT TO ALTERNATIVE SURGICAL TECHNIQUES. ON (B)(6) 2011 THE ISI CLINICAL SALES REPRESENTATIVE AND FIELD SERVICE ENGINEER PERFORMED IN-SERVICE TRAINING WITH THE SITE'S SURGICAL TEAM. THIS TRAINING INCLUDED TROUBLESHOOTING TECHNIQUES AND COMPONENT EXCHANGES. AS OF (B)(6) 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 HYSTERECTOMY PROCEDURE THE SITE EXPERIENCED A BACKWARDS IMAGE ON THE SURGEON SIDE CONSOLE MONITOR. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE) IT WAS DISCOVERED THAT THE SITE DID NOT HAVE THE ENDOSCOPE TURNED ON. THE SITE POWERED ON THE ENDOSCOPE AND EXPERIENCED A PINK AND GREEN IMAGE. THE TSE HAD THE SITE PERFORM SCOPE ALIGNMENT AND THE IMAGE APPEARED NORMAL. THE SITE CONTINUED WITH THE PROCEDURE. APPROXIMATELY 90 MINUTES LATER THE SITE CALLED BACK STATING THEY WERE EXPERIENCING A GREEN IMAGE IN THE RIGHT EYE OF THE HIGH RESOLUTION STEREO VIEWER. THE TSE HAD THE SITE REPLACE THE CAMERA CABLE, HOWEVER THE GREEN IMAGE REMAINED. THE TSE HAD THE SITE REPLACE THE CAMERA HEAD AND THE IMAGE APPEARED NORMAL. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED. UF MEDWATCH REPORT (B)(4) WAS RECEIVED (B)(6) 2011 REGARDING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other DA VINCI S SYSTEM, INSTRUMENTS AND ACCESSORIES