BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24694843 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18509
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    December 26, 2025
    Report Date
    April 9, 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
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. SYSTEM ISSUES RELATED TO ERROR MESSAGES/FAULTS CAN BE WORKED THROUGH WITH TROUBLESHOOTING MEASURES, SUCH AS REVIEWING LOGS. ERROR CODES LIKE ERROR 319 ARE AN INDICATION OF SYSTEM STATE. ERRORS OCCUR WHEN THE SYSTEM HAS DETECTED A POTENTIAL ISSUE, OR WHEN IT CANNOT BE SURE THERE IS NO ISSUE AND, THEREFORE, THE SYSTEM TRANSITIONS TO A SAFE ERROR STATE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED CAN'T CONFIRM NOR DENY THAT THE REPORTED DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. WHILE A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED SINCE THE REPORTED COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING, THE POTENTIAL ROOT CAUSE FOR THIS FAILURE CAN BE ATTRIBUTED TO COMMUNICATION ISSUES FROM THE FIBER OPTIC CABLES IN UNIVERSAL SURGICAL MANIPULATOR (USM) #3. THIS ISSUE CAN BE RESOLVED BY REPLACING THE USM OR DISABLING THE AFFECTED USM TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ERROR 319 ON THE UNIVERSAL SURGICAL MANIPULATORS (USM) PRIOR TO START, THE PROCEDURE WAS ABORTED. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331652 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 00886874110720

    Patients

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