BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2001958 · Received February 27, 2011

    Report

    Report Number
    2955842-2011-00058
    Event Type
    Other
    Date Received
    February 27, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE VISION ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE CAMERA CABLE. THE CAMERA CABLE CONNECTS THE CAMERA TO THE SYSTEM'S VISION CART, WHICH THEN TRANSMITS THE IMAGE TO THE SURGEON'S CONSOLE. THE SYSTEM WAS REPAIRED BY REPLACING THE DEFECTIVE CAMERA CABLE. 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 FEBRUARY 24, 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 SI MITRAL VALVE REPLACEMENT PROCEDURE, THE SITE EXPERIENCED A BLACK IMAGE IN THE LEFT EYE OF THE SURGEON SIDE CONSOLE. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE SURGICAL STAFF RESEATED THE CAMERA CABLE; HOWEVER, THE VISION ISSUE WAS NOT RESOLVED. AT THIS TIME, THE SURGICAL STAFF MADE THE DECISION TO CONVERT THE PLANNED PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT HARM OR ADVERSE OUTCOME 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. IS3000 A6.0P4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYS, INSTRUMENTS AND ACCESSORIES