BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24990717 · Received April 24, 2026

    Report

    Report Number
    2955842-2026-22946
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 24, 2026
    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
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 EVENT. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE DUE TO ERRORS C-06, M-18, AND M-11. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS NOT RECEIVED THE ERBE FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, SEVERAL RECURRING ERROR MESSAGES HAD OCCURRED ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE OVER ROUGHLY ONE TO ONE AND A HALF WEEKS, INCLUDING C-00, C-84, M-11, AND M-31. THE TECHNICAL SUPPORT ENGINEER (TSE) FIRST EXPLAINED THAT THE M-31 MESSAGE WAS RELATED TO INCOMPATIBLE GENERATOR SETTINGS DURING ENERGY ACTIVATION AND ADVISED THAT THE USER VERIFY THAT THE ENERGY SETTING ON THE GENERATOR WAS NOT AT ZERO; THE CUSTOMER WAS SATISFIED WITH THIS EXPLANATION. THE TSE THEN REVIEWED SYSTEM LOGS AND OBSERVED MULTIPLE INSTANCES OF C-06, M-11, AND M-18 OCCURRING TOGETHER. THE TSE ASKED THE CUSTOMER TO CONFIRM THAT THE GENERATOR HAD BEEN REBOOTED BETWEEN RECENT SURGERIES, WHICH THE CUSTOMER CONFIRMED. THE CUSTOMER ALSO REPORTED THEY HAD CHECKED THE FOOT PEDAL STORED IN THE DRAWER AND UNWRAPPED CABLES THAT HAD BEEN WRAPPED AROUND THE PEDAL, AS THIS COULD CAUSE UNINTENDED ACTIVATION AND INTERFERENCE. TSE AGREED THAT THE PEDAL COULD HAVE BEEN A ROOT CAUSE BUT NOTED THAT THIS HAD ALREADY BEEN ADDRESSED. TSE THEN INQUIRED ABOUT POSSIBLE ELECTROMAGNETIC INTERFERENCE SOURCES IN THE ROOM, SUCH AS MRI OR CT SYSTEMS OR OTHER DEVICES MOUNTED ON THE VISION SIDE CART (VSC), AND THE CUSTOMER CONFIRMED THAT NO SUCH EQUIPMENT WAS PRESENT AND THAT ONLY THE MANUFACTURER¿S DEVICES WERE INSTALLED ON THE VSC. WHEN THE CUSTOMER ASKED AGAIN ABOUT THE C-84 ERRORS, THE TSE EXPLAINED THAT THESE COULD BE RELATED TO HOW TISSUE WAS GRASPED OR TO A SHORT CIRCUIT BETWEEN THE ACTIVE AND NEUTRAL ELECTRODES ON A BIPOLAR INSTRUMENT, AND ADVISED SEPARATING THE JAWS AND REGRASPING TISSUE, CLARIFYING THAT THIS WAS NOT INDICATIVE OF A HARDWARE FAILURE. DUE TO THE RECURRING C-06, M-11, AND M-18 ERRORS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542502 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES