BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 9258370 · Received October 30, 2019

    Report

    Report Number
    2955842-2019-10860
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 15, 2019
    Report Date
    October 15, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    4307 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REDUNDANT MEDICAL GRADE POWER SUPPLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPLICATED THE REPORTED COMPLAINT. THE REDUNDANT MEDICAL GRADE POWER SUPPLY WAS INSTALLED INTO A TEST SYSTEM AND POWERED UP ON THE SURGEON SIDE CONSOLE (SSC) WITH ERROR 417 AND THE NUMBER TWO FAN WAS MAKING NOISE. IT WAS INDICATED THAT ERROR 417 MEANT THAT ONE OF THE REDUNDANT POWER SUPPLIES WAS FAILING.

    Additional Manufacturer Narrative · 1

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE SURGEON SIDE CONSOLE (SSC) WOULD NOT POWER ON. THE FSE REPLACED THE REDUNDANT MEDICAL GRADE POWER SUPPLY (RMGPS) (186610-02) TO RESOLVE THE SSC POWER ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT YET RECEIVED THE PART FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE SURGEON SIDE CONSOLE (SSC) HAD NO POWER. WHILE THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY, RECURRENCE OF THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER HAD NO POWER TO ONE OF THE SURGEON SIDE CONSOLE (SSC). THE CUSTOMER INFORMED THE TECHNICAL SERVICE ENGINEER (TSE) THAT THEY HAD ENCOUNTERED A NON-RECOVERABLE FAULT AND ONE OF THE TWO SSCS NO LONGER HAD POWER. THE TSE VIEWED THE SYSTEM EVENT LOGS AND CONFIRMED ERROR 417 INDICATING A POWER SUPPLY ERROR POINTING TO SSC 2. THE TSE NOTED AND CONFIRMED A COMMUNICATION FAULT FROM THE SSC 2 WHICH LED TO A NON-RECOVERABLE SYSTEM TIME OUT. IT WAS NOTED THAT THE CUSTOMER WAS PROCEEDING WITH THE CASE USING ONLY ONE SSC AND REQUESTED A FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP. THE TSE INDICATED THAT ALL TROUBLESHOOTING STEPS WERE COMPLETED WITH NO RESOLUTION. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTIC COORDINATOR INDICATED THE ISSUE WAS FIRST FOUND PRIOR TO STARTING WITH NO PORT PLACEMENT. IT WAS STATED THAT THEY WERE ABLE TO BRING UP THE SYSTEM WITH THE TWO SSC'S AND PROCEEDED WITH THE CASE. DURING THE CASE, THE ROBOTIC COORDINATOR INFORMED THEY ENCOUNTERED THE NON-RECOVERABLE ERROR AND THEN DECIDED TO CONTINUE ONLY USING THE SECOND SSC. THE ROBOTIC COORDINATOR CONFIRMED THE PROCEDURE WAS COMPLETED USING THE SECOND SSC WITH NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050622 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-10

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES