BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 9260278 · Received October 31, 2019

    Report

    Report Number
    2955842-2019-10864
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 21, 2019
    Report Date
    October 21, 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

    67 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PART(S) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPLICATED THE REPORTED COMPLAINT; HOWEVER, CONFIRMED THE ERROR OCCURRED VIA THE ERROR LOGS. THE UNIVERSAL MOTION CONTROLLER (UMC) BOARD WAS INSTALLED ON THE TEST SYSTEM AND NO ERRORS WERE TRIGGERED AND NORMAL SYSTEM OPERATION WAS OBSERVED. THE BOARD WAS TESTED IN FOLLOWING MODE FOR SEVERAL MINUTES WITH NO PROBLEMS. IT WAS NOTED THAT THE BOARD REMAINED IN THE SYSTEM FOR OVER TWO HOURS WHILE THE SYSTEM WAS BEING USED AND ERROR 95 NEVER WAS LOGGED. IT WAS NOTED THAT ERROR 95 INDICATED THAT A BOARD REPORTED A TEMPERATURE THAT WAS BEYOND THE OPERATING RANGE. FA FOUND THAT THE ANALOG TO DIGITAL CONVERTER (ADC) BOARD WAS READ AND NO ANOMALY WAS PRESENT. NO TROUBLE WAS FOUND WITH THE UMC BOARD.

    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) POWERED ON THE SYSTEM WITH NO ISSUE. IT WAS NOTED THAT THE FSE CLEANED THE PATIENT SIDE CART (PSC) CARD CAGE FILTER AND THEN REPLACED THE UNIVERSAL MOTION CONTROLLER (UMC) 2 (653140-07) TO RESOLVE THE REPEATED 95 ERROR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PART FOR EVALUATION; HOWEVER, THE EVALUATION IS IN PROGRESS. 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 PATIENT SIDE CART (PSC) SHUT DOWN. 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 EXPERIENCED THE SYSTEM SHUTTING DOWN DUE TO OVERHEATING. THE TECHNICAL SERVICE ENGINEER (TSE) VIEWED THE SYSTEM EVENT LOGS AND CONFIRMED AN ERROR 95 ENTRY INDICATING A HIGH TEMP FAULT POINTING TO THE UNIVERSAL MOTION CONTROLLER (UMC) 2 BOARD. PRIOR TO CALLING INTO TECHNICAL SUPPORT, THE CUSTOMER PERFORMED A SYSTEM POWER CYCLE AND WAS ABLE TO CLEAR THE FAULT; HOWEVER, THE FAULT SHORTLY RETURNED. THE TSE ASKED THE CUSTOMER IF ANOTHER PATIENT SIDE CART (PSC) WAS AVAILABLE AND IT WAS CONFIRMED THERE WAS NO OTHER PSC AVAILABLE. THE SURGEON ELECTED TO CONVERT TO LAPAROSCOPIC SURGERY. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SUPERVISOR INFORMED THEY HAD CALLED TECHNICAL SUPPORT SEVERAL TIMES. IT WAS NOTED THAT ALL TROUBLESHOOTING WAS COMPLETED. THE SUPERVISOR CONFIRMED THE PROCEDURE WAS CONVERTED TO LAP AND WAS COMPLETED WITH NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055916 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-20

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES