BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24142012 · Received January 22, 2026

    Report

    Report Number
    2955842-2026-01844
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 8, 2026
    Report Date
    January 21, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. THE FSE WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. THE UNIT WAS ANALYZED AND THE ISSUES WITH ERBE WERE CONFIRMABLE USING LOG REVIEWS; SIGNIFICANT NUMBER OF C-38, C-30, C-34, M-1 AND M-11 ERRORS LOGGED. C-06/M-18/M-11 ERROR PATTERN LOGGED, M-18 ERRORS LOGGED, C-01 LOGGED ALSO OF CONCERN. INSPECTION DURING FA PROCESS WAS ABLE TO FIND ERRORS IN ERBE LOGS THAT MATCH TIMEFRAME AND FAULT CONDITION REPORTED BUT WERE UNABLE TO REPLICATE ON SITE. C-00, M-11 ERRORS IN ERBE LOGS. UNIT TESTED ON SYSTEM, NO ERRORS ON STARTUP OR DURING USE. ALL OPERATIONS PERFORMED SUCCESSFULLY VIA ALL PORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY ENCOUNTERED AN ISSUE WITH THE MONOPOLAR ENERGY, SPECIFICALLY THE MONOPOLAR COAGULATION FUNCTION, WHILE THE CUT FUNCTION REMAINED OPERATIONAL. THE TSE REVIEWED THE LOGS AND CONFIRMED THE ISSUE. INITIAL TROUBLESHOOTING INVOLVED RECOMMENDING A POWER CYCLE OF THE ERBE GENERATOR, SWAPPING MONOPOLAR PORTS AND ENERGY CABLES, AND CHANGING THE INSTRUMENT, BUT THESE STEPS DID NOT RESOLVE THE PROBLEM. THE ISSUE PERSISTED INTERMITTENTLY EVEN AFTER CHANGING THE INSTRUMENT. THE TSE THEN SUGGESTED ADJUSTING THE COAG SETTINGS TO FORCED OR CLASSIC TO LIMIT THE ENERGY TO THE INSTRUMENT. THE USER CONTINUED WITH THE PROCEDURE AS PLANNED WITH NO REPORT INJURIES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT SWITCHING TO CLASSIC MODE DID NOT RESOLVE THE ISSUE. THEY CONTINUED WITH THE PROCEDURE USING THE SAME ERBE GENERATOR WITHOUT USING THE COAGULATION MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204142 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-31 N/A 00886874110898

    Patients

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