BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2132971 · Received June 17, 2011

    Report

    Report Number
    2955842-2011-00185
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE CAMERA HEAD. THE CAMERA HEAD PRODUCES THREE DIMENSIONAL IMAGES TO THE DA VINCI SYSTEM THROUGH RIGHT AND LEFT OPTICAL PATHS. THE IMAGES ARE ACQUIRED THROUGH SEPARATE OPTICAL CHANNELS OF THE ENDOSCOPE AND ARE DIRECTED TO THE CAMERA HEAD AND PROCESSED INDEPENDENTLY. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED CAMERA HEAD. THE CAMERA HEAD WAS RETURNED AND EVALUATED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). THE OEM OBSERVED THAT THE CAMERA STAGE WAS DAMAGED, THUS CAUSING THE VISION ISSUE EXPERIENCED BY THE CUSTOMER. 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 BACKUP EQUIPMENT AND INSTRUMENTATION AVAILABLE, AND BE PREPARED TO CONVERT TO ALTERNATIVE SURGICAL TECHNIQUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY THE SURGEON EXPERIENCED A DEPTH PERCEPTION ISSUE BETWEEN THE LEFT AND RIGHT EYE OF THE SURGEON CONSOLE. THE SYSTEM WAS RESTARTED, HOWEVER, THIS ACTION WAS UNABLE TO RESOLVE THE VISION ISSUE. 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 SURGICAL SYSTEM, INSTS & ACCS