BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2132966 · Received June 17, 2011

    Report

    Report Number
    2955842-2011-00182
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 A FAULTY 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 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. 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 SI NEPHRECTOMY PROCEDURE, THE SITE EXPERIENCED A LOSS OF VISION IN THE RIGHT EYE IMAGE OF THE HIGH STEREO RESOLUTION VIEWER (HRSV). WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER THE SURGICAL STAFF RESEATED THE VISION CABLE ON BOTH ENDS AND RESTARTED THE SYSTEM, HOWEVER, THE VISION ISSUE WAS NOT RESOLVED. THE SURGICAL STAFF MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED 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 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYSTEM INSTRUMENTS & ACCESSORIES