BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 23433619 · Received October 31, 2025

    Report

    Report Number
    2955842-2025-43554
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 6, 2025
    Report Date
    October 30, 2025
    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
    GA, 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 EVENT. THE FSE CONFIRMED THE ERRORS POINTING TO THE MASTER TOOL MANIPULATOR (MTM) AND REPLACED MTM TO RESOLVE THE REPORTED 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 MTM WAS ANALYZED AND A REVIEW OF THE FIELD LOGS SHOWED MULTIPLE ERROR CODE OF 23008. DURING SYSTEM TESTING, ERROR CODE 23152 WAS OBSERVED. AFTER INSTALLING AND RUNNING THE FITNESS TEST, THE MTM FAILED FOR BACKDRIVE AND ERROR CODE 23008 WAS OBSERVED FOR THE ROLL AXIS. THE MTM ALSO FAILED FOR VERIFY ENCODER CALIBRATION. DURING VISUAL INSPECTION ROLL MAGNET DELAMINATION WAS OBSERVED. THIS FAILURE LIKELY CAUSED THE ERROR CODE 23008 FAILURES OBSERVED. ADDITIONAL FINDINGS OF FAILURES FOR SLOW GRAVITY BALANCE TEST POST SINE CYCLE FOR WRIST PITCH (AXIS 5) - RIPPLE_TORQUE_MAX DURING THE FITNESS TEST WAS OBSERVED. THE PROBABLE ROOT CAUSE IS DUE TO AN ISSUE WITH THE GEARBOX WITHIN THE GIMBAL ON THE MTM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD RECOVERABLE FAULT POINTING TOWARDS RIGHT HAND CONTROL ON THE SURGEON CONSOLE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING CHOLECYSTECTOMY PROCEDURE, THE ERROR ON THE RIGHT-HAND CONTROL HAD OCCURRED, AND THE SURGEON CONVERTED THE PROCEDURE TO LAPAROSCOPY. THE PORT SIZE WAS NOT INCREASED, OR THE ADDITIONAL PORTS WERE NOT PLACED FOR THE LAPAROSCOPIC PROCEDURE. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713835 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-45 N/A 00886874119747

    Patients

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