BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 24694245 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17801
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    December 17, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM WAS ANALYZED AND IN ARTEMIS, THE ERROR 319 WAS FOUND INDICATING NODE 192 IS NOT PRESENT AT STARTUP, NODE NAME: AXES CONTROLLER CARRIAGE (ACC), CONFIRMING THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, THE ROLLING LOOP FIBER WAS FOUND TO BE DAMAGED, REPLICATING THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE ERROR 319 WAS TRIGGERED WITH NODE NOT PRESENT AT STARTUP POINTING TO ACC. THE USM WAS THEN INSTALLED ONTO A PATIENT SITE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE CHECK ALL BOARDS FAILED FOR ACC. ONCE TESTING WAS COMPLETED, THE ROLLING LOOP FIBER WAS TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED ERRORS. TECHNICAL SERVICE ENGINEER (TSE) GUIDED CUSTOMER THROUGH A HARD POWER CYCLE OF THE SYSTEM AND VERIFIED ALL BLUE FIBER CABLE CONNECTIONS. UPON POWERING UP, ERROR 319 APPEARED FOR UNIVERSAL SURGICAL MANIPULATOR (USM) 3. CUSTOMER DISABLED USM 3, AND THE SYSTEM DISPLAYED ¿DA VINCI IS READY¿. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62042 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-35 00886874115404

    Patients

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