BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 24694154 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17967
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    September 16, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE FSE CONFIRMED THE ERRORS ON THE SYSTEM POINTING TO THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND REPLACED THE 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 FOUND TO FAIL THE SINE CYCLE ON THE YAW AXIS WHEN INSTALLED ON A TEST FIXTURE. BASED ON THE COMPLAINT THE YAW SEARCHLIGHT ASSEMBLY WITH PRINTED CIRCUIT ASSEMBLY (PCA) WAS DETERMINED TO BE CONSISTENT WITH THE ISSUE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ISI REVIEWED THE SITE¿S COMPLAINT HISTORY, WHICH SHOWS NO RELATED RECORD. A REVIEW OF THE SITE¿S SYSTEM LOGS REVEAL ERROR 23008 ERRORS POINTING TO THE USM. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT WAS NOT PERFORMED, AS THE APPLICABLE PRODUCT IS A SYSTEM COMPONENT THAT HAS BEEN SERVICED POST-MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ERROR 23008 OCCURRED WHEN BOOTING UP THE SYSTEM. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED THE ERROR POINTED TO AXIS1 OR 2 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THIS ISSUE WAS NOT RESOLVED BY EMERGENCY POWER OFF (EPO) CYCLE AND STRETCHING USM 3. FSE ADVISED HOW TO DISABLE USM 3. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTED PORTS WERE NOT PLACED PRIOR TO THE ISSUE BEING IDENTIFIED AND BECAUSE THE ISSUE OCCURRED BEFORE PORT PLACEMENT, AND THE SURGEON DID NOT WANT TO PERFORM THE PROCEDURE WITH THREE ARMS, THEY CHANGED THE PROCEDURE TO LAPAROTOMY. THE CONVERSION DID NOT RESULT IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS AND THE PATIENT TOLERATED THE CHANGE WITH NO PATIENT INJURY. THE SYSTEM FUNCTIONALITY CHECKED UPON POWERING ON THE SYSTEM AND IT POWERED ON WITHOUT ANY ERRORS. DVSTAT WAS CONTACTED FOR TROUBLESHOOTING AND FULL TROUBLESHOOTING WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351597 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-38

    Patients

    Seq Age Sex Outcome Treatment
    1