BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25326886 · Received May 29, 2026

    Report

    Report Number
    2955842-2026-26846
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 2, 2026
    Report Date
    May 28, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WAS UNABLE TO INDUCE REPORTED DISCREPANCY THROUGH ERROR LOGS DUE TO DIFFERENT COMPONENTS BEING USED. FSE CONFIRMED WITH THE CUSTOMER THAT A DIFFERENT TOWER WAS USED WHEN ERROR OCCURRED. HOWEVER, FSE WAS ABLE TO CONFIRM REPORTED DISCREPANCY THROUGH SYSTEM LOGS. THE FSE PROCEEDED TO REPLACE DISTAL SET UP JOINT (SUJ). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE SUJ TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS BUT WAS NOT ABLE TO REPRODUCE THE ISSUE DURING IN-HOUSE TESTING. UPON VISUAL INSPECTION, THE J11 CONNECTOR ON THE SETUP FIELD REPLACEMENT UNIT LOWER (SFL) PRINTED CIRCUIT ASSEMBLY (PCA) WAS FOUND LOOSE WHICH COULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM, WHERE NO ERRORS WERE TRIGGERED AND IT PERFORMED AS EXPECTED IN NORMAL MODE. THE UNIT WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM WHERE IT PASSED ALL RELEVANT TESTING. THE PROBABLE ROOT CAUSE IS AN ELECTRICAL COMPONENT IN THE SFL PCA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED A NON-RECOVERABLE FAULT ON ARM 3. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED SYSTEM LOGS AND CONFIRMED THE NONRECOVERABLE FAULTS ASSOCIATED WITH THE ARM. THE TSE RECOMMENDED TO POWER CYCLE THE SYSTEM. THE CUSTOMER STATED THAT ONE OF THE INSTRUMENTS WAS ACTUALLY GRASPING ANOTHER INSTRUMENT, SO THEY NEEDED TO USE THE INSTRUMENT RELEASE KIT (IRK) FIRST. AFTER THE IRK WAS USED ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT, THE CUSTOMER WAS ABLE TO REMOVE THE REMAINING INSTRUMENTS AND POWER CYCLE THE SYSTEM. THE SYSTEM POWERED BACK ON SUCCESSFULLY AND THE CUSTOMER INSTALLED THE INSTRUMENTS. THE SURGEON WAS NOW PROCEEDING WITH CASE. THE TSE ADVISED THE CUSTOMER THAT SINCE THE IRK WAS USED ON THE INSTRUMENT, IT IS HIGHLY RECOMMENDED NOT TO USE THE SUSPECT INSTRUMENT. CUSTOMER AGREED AND GRABBED ANOTHER FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO SWAP IT OUT. THE CUSTOMER WAS PROCEEDING WITH THE CASE. LATER ON, THE CUSTOMER CALLED BACK TO REPORT THAT THE SYSTEM WAS STILL FAULTING AFTER RESTART. SYSTEM NOW SHOWED ERROR 319 AND REQUESTING TO DISABLE ARM 3 TO CONTINUE. THE CUSTOMER WAS GOING TO DISABLE ARM 3 AND CONTINUE THE PROCEDURE WITH 3 ARMS. TSE INFORMED CUSTOMER THAT ARM 3 WOULD NOT BE AVAILABLE ON SYSTEM UNTIL SERVICE IS PERFORMED AND CASE IS BEING OPENED FOR THE SERVICE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496373 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1