BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 9679350 · Received February 6, 2020

    Report

    Report Number
    2955842-2020-10081
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 16, 2020
    Report Date
    January 16, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE NOTED THAT THE VISION SIDE CAT (VSC) WAS FROZEN ON START UP AND A SPINNING WHEEL WAS DISPLAYED. THE VSC WOULD NOT POWER ON AND WOULD ONLY STAY ON AN AMBER LIGHT EVEN WHEN TURNED ON FROM ANOTHER CONSOLE. THE FSE WAS UNABLE TO LOG INTO THE SYSTEM AND COULD ONLY HAVE LIMITED ACCESS AS A STAND ALONE SYSTEM. THE FSE TRIED REPLACING THE INTUITIVE SURGICAL CORE POWER DISTRIBUTION (IPD) BUT HAD NO SUCCESS IN RESOLVING THE ISSUE. THE FSE REPLACED THE ISI CORE CONTROLLER (ICC) WHICH RESOLVED THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PARTS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION COULD NOT REPRODUCE THE REPORTED FAILURE WITH THE IPD. THE IPD WAS INSTALLED INTO THE TEST SYSTEM, A TEN MINUTES SINE CYCLE WAS RUN, TWENTY POWER CYCLES WERE RUN, AND THE SYSTEM WAS LEFT SITTING IDLE FOR 1 HOUR WITHOUT ANY ERRORS NOTED. NO TROUBLE WAS FOUND WITH THE IPD. FAILURE ANALYSIS INVESTIGATION REPLICATED THE REPORTED FAILURE WITH THE ICC. THE ICC WAS INSTALLED INTO THE TEST SYSTEM. THE SYSTEM WAS NOT ABLE TO BE POWERED ON. THE CORE STAYED AMBER AND WOULD NOT POWER ON FROM OTHER CARTS. THE ICC WAS THEN REMOVED AND POWERED ON AT THE BENCH. THE BOARD WAS NOT ABLE TO BE POWERED ON FROM THE BENCH. ONLY ONE GREEN 12 V LIGHT EMITTING DIODE (LED) WAS FOUND TO BE LIT UP. IT WAS CONCLUDED THAT THE ICC BOARD HAD A POWER PROBLEM. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NISSEN FUNDOPLICATION SURGICAL PROCEDURE, A NON-RECOVERABLE ERROR OCCURRED. IT WAS REPORTED THAT THE SURGEON INDICATED THAT THEY HAD NO CONTROL OF THE ARMS AND FOLLOWING THAT, THE SYSTEM FAULTED WITH ERROR 252. THE CUSTOMER STATED THAT ALL INSTRUMENTS WERE GRASPING TISSUE AND THEY HAD NO VISION AND WERE NOT ABLE TO REMOVE INSTRUMENTS. THE TECHNICAL SUPPORT ENGINEER (TSE) INFORMED THE CUSTOMER THAT THE INSTRUMENTS SHOULD NOT MOVE. IT WAS REPORTED THAT THE CUSTOMER ATTEMPTED TO POWER CYCLE THE SYSTEM AND THE SYSTEM WOULD NOT TURN OFF. PER THE TSE'S SUGGESTION, THE CUSTOMER PERFORMED AN EMERGENCY POWER OFF (EPO), CYCLED ALL BREAKERS ON ALL COMPONENTS, AND RESEATED ALL BLUE FIBER CABLES. THE CUSTOMER STATED THAT THE VISION TOWER POWER BUTTON REMAINED AMBER WHEN THE PATIENT SIDE CART (PSC) POWER BUTTON WAS PRESSED. IT WAS REPORTED THAT THE CUSTOMER TRIED POWER CYCLING THE VISION TOWER BREAKER SEVERAL MORE TIMES AND LEFT THE POWER OFF FOR A MINUTE BUT THE VISION TOWER WOULD NOT TURN ON WHEN ITS POWER BUTTON WAS PRESSED. THE TSE RECOMMENDED USING AN EXTERNAL CAMERA TO VISUALIZE INSTRUMENTS AND USE THE INSTRUMENT RELEASE KIT (IRK) TO RELEASE TISSUE AND REMOVE INSTRUMENTS. IT WAS REPORTED THAT THE CUSTOMER UNDOCKED THE SYSTEM AND INTENDED TO CONVERT THE PROCEDURE. THE CLINICAL SALES REPRESENTATIVE (CSR) THEN CALLED TECHNICAL SUPPORT TO TROUBLESHOOT THE SYSTEM. PER THE TSE'S SUGGESTION, THE CSR HARD CYCLED AND EPO'ED THE PSC AGAIN BUT NO CHANGE WAS OBSERVED. ALL TROUBLESHOOTING STEPS WERE PERFORMED TO RESOLVE THE REPORTED ISSUE; HOWEVER, THE ISSUE PERSISTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED DURING SYSTEM SET-UP. THE REPORTED ISSUE OCCURRED TOWARDS THE END OF THE CASE AND THE SURGEON ONLY HAD ONE MORE STITCH TO FINISH SO THE ROBOT WAS UNDOCKED AND THE PROCEDURE WAS FINISHED LAPAROSCOPICALLY. NO INJURY OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138590 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-27

    Patients

    Seq Age Sex Outcome Treatment
    1