BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1590517 · Received January 29, 2010

    Report

    Report Number
    2955842-2010-00031
    Event Type
    Injury
    Date Received
    January 29, 2010
    Date of Event
    December 30, 2009
    Report Date
    December 30, 2009
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K012833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) - THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE). THE FSE FOUND NO ERROR CODES ASSOCIATED WITH THE REPORTED MALFUNCTION WHEN REVIEWING THE SYSTEM ERROR LOGS AND WAS UNABLE AND TO REPLICATE THE REPORTED FAILURE MODE. FUNCTIONAL TESTING OF THE SYSTEM REVEALED THAT THE PATIENT SIDE MANIPULATOR (PSM) ON WHICH THE MICRO BIPOLAR FORCEPS INSTRUMENT WAS INSTALLED FUNCTIONED NORMALLY, HOWEVER, AN AXIS OF THE PSM WAS FOUND TO BE OUT OF TOLERANCE. ALTHOUGH THE PSM AXIS WAS FOUND TO BE OUT OF TOLERANCE, IT IS HIGHLY UNLIKELY THAT THE FAILURE MODE IN ITSELF WOULD HAVE CAUSED OR CONTRIBUTED TO THE INSTRUMENT JUMP EXPERIENCED BY THE CUSTOMER. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE AFFECTED PSM WAS REPLACED TO REPAIR THE SYSTEM. A DVD OF THE RECORDED PROCEDURE WAS RETURNED TO ISI FOR REVIEW. ENGINEERING OBSERVED A SUDDEN MOTION OF THE INSERTION AXIS OF THE PSM CAUSING THE INSTRUMENT TO PIERCE THE PATIENT'S ARTERY. THE DISTANCE TRAVELED APPEARED TO BE LARGER THAN 1CM. ENGINEERING ALSO OBSERVED OTHER INSTANCES WHERE THE INSTRUMENT TIP APPEARED TO MAKE SUDDEN MOVEMENTS, HOWEVER, THEY WERE OF A SMALLER MAGNITUDE THAN THE MOVEMENT THAT CAUSED DAMAGE TO THE PATIENT'S ARTERY. ENGINEERING CONCLUDED THAT THE ROOT CAUSE OF THE INSTRUMENT MOVEMENT WAS DUE TO MOTION BEING IMPEDED BY A LARGE AMOUNT OF STATIC FRICTION. THE SOURCE OF THE FRICTION IS UNKNOWN. SOME OF THE POSSIBLE SOURCES ARE STERILE DRAPE, A BENT INSTRUMENT, OR A BENT CANNULA. IN THIS CASE, THE SURGEON WOULD MOVE THE MASTER TOOL MANIPULATOR (MTM) AND THE INSTRUMENT WOULD NOT MOVE INITIALLY DUE TO THE FRICTION, HOWEVER, ONCE THE SURGEON MOVED FAR ENOUGH FOR THE INSTRUMENT TO OVERCOME THE FRICTION, THE INSTRUMENT COULD MAKE A QUICK JUMP TO CATCH UP WITH THE MTM. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLER WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENT AND ENDOSCOPE INSIDE THE PATIENT. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE, HOWEVER, THE AXIS OUT OF TOLERANCE ISSUE WAS CONFIRMED AND IT WAS DETERMINED THAT THE AXIS POTENTIOMETER AND MOTOR/ENCODER HAD MALFUNCTIONED. AS OF (B) (6) THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT WHILE MOBILIZING THE LEFT INTERNAL MAMMARY ARTERY DURING A DA VINCI S CABG PROCEDURE, THE MICRO BIPOLAR FORCEPS (MBF) INSTRUMENT JUMPED FORWARD AND PUNCTURED THE PATIENT'S ARTERY. THE DAMAGED SECTION OF THE ARTERY WAS TRANSECTED AND THE HEALTHY PORTION OF THE ARTERY WAS USED TO COMPLETE THE BYPASS. IT WAS ALSO REPORTED THAT THROUGHOUT THE CASE, PNEUMO WAS ESTABLISHED AND LOST SEVERAL TIMES. THE ISI REPRESENTATIVE PRESENT DURING THE PROCEDURE INDICATED THAT PRIOR TO THE MBF INSTRUMENT JUMP, THE SURGEON NOTED THAT WHEN THE MASTER TOOL MANIPULATOR WAS MOVED, THE INSTRUMENT FELT STUCK AND THEN MOVED. IT IS BELIEVED THAT THE SURGEON CAUGHT THE MBF INSTRUMENT IN THE PATIENT'S RIB. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES OR PATIENT HARM.

    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 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention DA VINCI S SYST, INSTRUMENTS, ACCESSORIES & ESU