BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1416635 · Received April 24, 2009

    Report

    Report Number
    2955842-2009-00143
    Event Type
    Other
    Date Received
    April 24, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 1, 2009
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS - THE INVESTIGATION CONDUCTED BY AN ISI FIELD SERVICE ENGINEER (FSE) CONFIRMED THE CUSTOMER REPORTED FAILURE AS THE ASSISTANT MONITOR DID NOT DISPLAY ANY VIDEO AND THE MESSAGE "COMPOSITE SEARCHING" WAS DISPLAYED. THE FSE SWITCHED THE MONITOR SETTING TO SDI VIDEO; HOWEVER, THERE WAS NO IMAGE DISPLAY. REVIEW SYSTEM ERROR LOGS FOR THE DAY DID NOT REVEAL ANY UNUSUAL ERRORS. EXAMINATION OF THE CONNECTIONS AND SETTINGS ON THE VSC LIGHT FOUND THAT THE GREEN LIGHT FOR THE DIGITIZER WAS NOT PRESENT. REMOVAL OF THE SIDE CONNECTIONS REVEALED THAT THE SITE'S ELECTROSURGICAL UNIT (ESU) WAS PRESSED AGAINST 3 PLUGS ON THE ISOLATION TRANSFORMER AND WERE UNSEATED. ONE OF THE AFFECTED PLUGS WAS THE DIGITIZER POWER CORD. THE FSE CONCLUDED THAT ESU PRESSED AGAINST THE 3 PLUGS CAUSING THE LOSS OF POWER. THE VIDEO WAS RESTORED TO THE ASSISTANT AND EXTERNAL MONITORS WHEN THE ESU AND PLUGS WERE RESEATED. AS OF (B)(6) 2009 THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 20 MINUTES INTO A DA VINCI S GYNECOLOGICAL SURGICAL PROCEDURE WHILE DOCKING THE SYSTEM, THE VISION SIDE CART (VSC) TOUCH SCREEN IMAGE WENT BLACK WITH THE MESSAGE "SDI SEARCHING" DISPLAYED IN THE LOWER RIGHT CORNER. THE EXTERNAL MONITOR CONNECTED TO THE CONSOLE ALSO WENT BLACK. WITH ASSISTANCE OF A TECHNICAL SUPPORT ENGINEER (TSE) THE SITE MOVED THE TOUCH SCREEN THROUGH IT'S RANGE OF MOTION, CHECKED THE VIDEO CABLES LOCATED AT THE REAR OF THE DIGITIZER AND THE CONSOLE, CONNECTED THE COMPOSITE CABLE TO THE DIGITIZER, CONNECTED ANOTHER MONITOR TO THE COMPOSITE CABLE, AND TRIED THE VSC AND CONSOLE CONNECTION; HOWEVER, THE IMAGE DID NOT RETURN. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PT 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 A5.1P7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SURGICAL SYSTEM| ACCESSORIES| INSTRUMENTS