BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 8075673 · Received November 15, 2018

    Report

    Report Number
    2955842-2018-10673
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 26, 2018
    Report Date
    January 14, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) RECEIVED THE HIGH RESOLUTION STEREO VIEWER (HRSV) MONITOR ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. THE OEM CONFIRMED THE REPORTED ISSUE ¿ RIGHT IS BLACK IN CONSOLE. OEM FOUND THAT THE MONITOR HAD NO IMAGE AND THE MAIN BOARD HAS A DEFECT. THE PRINTED CIRCUIT ASSEMBLY MAIN BOARD WAS REPLACED TO ADDRESS THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING REPORTED DUE TO A DA VINCI SYSTEM MALFUNCTION RENDERING THE DA VINCI SYSTEM UNAVAILABLE FOR USE AFTER THE START OF A SURGICAL PROCEDURE. ALTHOUGH NO PATIENT HARM OCCURRED, IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, THE RIGHT EYE IN THE SURGEON SIDE CONSOLE¿S (SSC) HIGH RESOLUTION STEREO VIEWER (HRSV) WAS BLACK. THE CUSTOMER REBOOTED THE SYSTEM WITH NO CHANGE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ATTEMPTED TROUBLESHOOTING BY HAVING THE CUSTOMER REBOOT THE SYSTEM ONCE AGAIN, CYCLING THE CIRCUIT BREAKER ON THE SSC, AND CLEANING AND RESEATING THE FIBER CABLES BUT THE ISSUE PERSISTED. AT THAT TIME, THE SURGEON MADE THE DECISION TO CONVERT AND COMPLETE THE PROCEDURE USING TRADITIONAL LAPAROSCOPIC TECHNIQUES. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. ISI FOLLOWED UP WITH THE SITE¿S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT HANDLED THE CONVERSION TO LAPAROSCOPIC SURGERY WELL. AT THIS TIME, THE PATIENT IS IN NORMAL RECOVERY AND IN ¿VERY GOOD¿ CONDITION. THE ROBOTICS COORDINATOR ESTIMATED THAT APPROXIMATELY TWENTY MINUTES PASSED FROM THE TIME THE PATIENT WAS DOCKED TO THE TIME THAT THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. THE ROBOTICS COORDINATOR CONFIRMED THAT THE IMAGE LOOKED NORMAL/FINE WHILE CHECKING THE SYSTEM FROM THE VISION SIDE CART TOUCHSCREEN. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE CONFIRMED THAT THE RIGHT EYE IN CONSOLE WAS NOT TURNING ON. THE FSE NOTED THE LEFT EYE WAS WORKING FINE BUT THE RIGHT EYE HAD NO IMAGE. THE FSE RESTORED THE RIGHT EYE IMAGE AFTER REPLACING THE RIGHT HRSV. THE HIGH RESOLUTION STEREO VIEWER IS LOCATED ON THE SURGEON SIDE CONSOLE AND PROVIDES THE 3D IMAGE CAPTURED FROM THE ENDOSCOPE INSERTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915819 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-31

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES