BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24691930 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17852
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    November 21, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 REPLACED THE AFFECTED MASTER TOOL MANIPULATOR (MTM) TO RESOLVED 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. IN THE SYSTEM LOGS, THE 23062 ERROR WAS FOUND INDICATING A FAILURE ON THE WRIST YAW AXIS, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND DRIVEN WITH AN IN-HOUSE INSTRUMENT. NO ISSUES WERE OBSERVED AND THE UNIT PASSED SYSTEM TEST. AFTER INSTALLING ON SURGEON SIDE CONSOLE FIXTURE TEST PLATFORM (SFTP) AND RUNNING THE FITNESS TEST, THE UNIT FAILED VARIOUS CALIBRATION TESTS. AFTER RUNNING CALIBRATION, ALL TESTS PASSED SUCCESSFULLY. 1HR SLOW SPEED SINE CYCLE ON THE WRIST YAW AXIS WAS PERFORMED AND PASSED. 23062 ERROR WAS NOT OBSERVED DURING SFTP TESTING. THE EVENT WAS CONFIRMED BASED ON ERROR LOG REVIEW; HOWEVER, THE ISSUE WAS NOT ABLE TO BE REPLICATED DURING IN-HOUSE TESTING. WHILE A DEFINITIVE ROOT-CAUSE CANNOT BE ESTABLISHED SINCE THE REPORTED COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING, A POTENTIAL ROOT CAUSE FOR THIS FAILURE CAN BE ATTRIBUTED TO A FAULT ON THE WRIST YAW MOTOR AND THE SLIPRING. THIS ISSUE CAN BE RESOLVED BY REPLACING THE AFFECTED MTM VIA FSE SERVICE OR SWITCHING TO A DIFFERENT SURGEON SIDE CONSOLE (SSC).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, THE CUSTOMER REPORTED REPEATED ERROR 23062 ONTHE SYSTEM. MULTIPLE EMERGENCY POWER OFF (EPO) WERE COMPLETED BUT ISSUE PERSISTED. ERROR WAS PRESENT IN BOTH, STAND ALONE/SIM MODE AND ALSO WHEN CONNECTED TO THE SYSTEM. TECHNICAL SUPPORT ENGINEER (TSE) ENSURED NO ERGONOMICS OR HEAD IN VIEWER WHEN THE CONSOLE WAS INITIALIZING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556477 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-46 N/A 00886874119747

    Patients

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