BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2133039 · Received June 17, 2011

    Report

    Report Number
    2955842-2011-00188
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER DETERMINED THAT THE CUSTOMER REPORTED ISSUE WAS ASSOCIATED WITH THE CAMERA CABLE, CAMERA HEAD AND VIDEO DIGITIZER. THE CAMERA CABLE CONNECTS THE CAMERA TO THE SYSTEM'S VISION CART, WHICH THEN TRANSMITS THE IMAGE TO THE SURGEON'S CONSOLE. THE CAMERA HEAD PRODUCES THREE DIMENSIONAL IMAGES TO THE DA VINCI 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 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 CAMERA CABLE, CAMERA HEAD AND VIDEO DIGITIZER. THE COMPONENTS WERE RETURNED AND EVALUATED. ENGINEERING NOT ABLE TO REPLICATE THE REPORTED FAILURE MODE WITH THE CAMERA CABLE AND DIGITIZER; HOWEVER, DID REPRODUCE THE REPORTED FAILURE MODE ON THE RETURNED CAMERA HEAD. THE CAMERA HEAD SHOWED EVIDENCE OF MECHANICAL SHOCK RESULTING IN DAMAGED STAGE ASSEMBLY THUS CAUSING THE REPORTED COMPLAINT. THE DA VINCI SI SURGICAL SYSTEM USER'S MANUAL EXPLICITLY STATES THAT, ENVIRONMENTAL OR EQUIPMENT FAILURES MAY CAUSE THE DA VINCI SI SYSTEM TO BECOME UNAVAILABLE. THE SURGICAL TEAM SHOULD ALWAYS HAVE BACKUP EQUIPMENT AND INSTRUMENTATION AVAILABLE, AND BE PREPARED TO CONVERT TO ALTERNATIVE SURGICAL TECHNIQUES. 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 PRIOR TO USING THE SYSTEM TO PERFORM ANY SURGICAL TASKS FOR A DA VINCI S PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF WAS UNABLE TO FOCUS THE CAMERA. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE SITE ATTEMPTED TO TROUBLESHOOT THE SYSTEM; HOWEVER THEY DID NOT HAVE A BACK UP CAMERA CABLE OR CAMERA HEAD. THE PATIENT HAD BEEN UNDER ANESTHESIA FOR 2 HOURS WHEN THE SURGEON MADE THE DECISION TO ABORT THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 5.1P8

    Patients

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