BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15832793 · Received November 21, 2022

    Report

    Report Number
    2955842-2022-15312
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    October 17, 2022
    Report Date
    October 17, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE SURGEON SIDE CART (SSC) FOOT TRAY TO CORRECT THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE SSC FOOT TRAY WAS RETURNED FOR FURTHER INVESTIGATION AND THE REPORTED EVENT COULD NOT BE REPRODUCED BUT WAS CONFIRMED THROUGH LOGS. WHEN REVIEWING THE LOGS, THERE WERE SEVERAL ERRORS 31073 WITH P2 VALUE 1 WHICH MEANS: THE FOOT TRAY'S POSITION SENSORS HAVE NOT BEEN SEEN AS UNBLOCKED, RIGHT FOOT SENSOR STATUS ITS BLOCKED. THE FOOTREST WAS INSTALLED AND TESTED IN THE TEST SYSTEM WITHOUT ANY ISSUES. THE TEST WITH THE PEDALS TO INSTRUMENT SWAP AND MONOPOLAR AND BIPOLAR WORKED WELL, ALL THE BUTTONS ON THE FOOT SWITCH WORKED NORMALLY. TEN POWER CYCLES WERE PERFORMED WITHOUT ANY ISSUES. PROCEDURE VERIFICATION WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: SYSTEM (B)(4)., EVENT DATE (B)(6) 2022, AND PROCEDURE NAME RADICAL CYSTECTOMY. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER SWITCHED TO ANOTHER SURGEON SIDE CONSOLE (SSC) AFTER THE START OF THE PROCEDURE DUE TO THE MONOPOLAR WAS NOT FIRING. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY SURGICAL PROCEDURE, THE MONOPOLAR ENERGY WAS NOT WORKING FROM ONE SURGEON SIDE CONSOLE (SSC). THE CUSTOMER SWITCHED TO THE OTHER SSC TO CONTINUE WITH CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE ON (B)(6) 2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SITE TRIED A NEW MONOPOLAR CORD BEFORE THE SURGEON MOVED TO THE NEW SSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909081 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-23 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES