BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24694622 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17963
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    August 18, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 SETUP JOINT (SUJ) 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 SUJ WAS ANALYZED AND IN ARTEMIS, ERROR 220028 WAS CONFIRMED INDICATING THAT THE MANIPULATOR HAS FAILED POWER-ON-SELF-TEST MORE THAN A SPECIFIED NUMBER OF TIMES. ERROR 23007 WAS ALSO CONFIRMED, INDICATING THAT THE SERVO SYSTEM WAS UNABLE TO CONTROL THE ARM WITHIN EXPECTED TOLERANCES DURING THE WIGGLE TEST PERFORMED AFTER HOMING, POINTING TO THE SUJ-Z (VERTICAL) AXIS. INSTALLED THE PROXIMAL ONTO A GOLDEN SYSTEM WHERE NO FAULTS OCCURRED IN NORMAL MODE. VSUJ GOT STUCK DURING POST, BUT WAS ABLE TO COMPLETE POST WITHOUT FAULTS. TESTED THE PROXIMAL ON A PFTP WHERE IT PASSED ALL RELEVANT TESTING. AFTER TESTING WAS COMPLETE, VISUAL INSPECTION FOUND SIGNIFICANT RESIDUE ALONG THE VERTICAL BRAKE PAD AND AGAINST THE BRAKE. THE COMPLAINT WAS CONFIRMED BASED ON 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 PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ARM 4 WAS NOT INITIALIZING UNTIL THE VERTICAL SECTION OF THE ARM WAS PULLED DOWN, AT WHICH POINT THE ARM LED'S TURNED BLUE. ERROR LOGS WERE UPLOADED AND REVIEWED, REVEALING ERROR CODES 22028 AND 23007 ASSOCIATED WITH THE VERTICAL SETUP JOINT (SUJ) ON ARM 4. THE CUSTOMER DECIDED TO CONFIGURE THE SYSTEM FOR A THREE-ARM PROCEDURE. THE ISSUE WAS NOTED WHEN THE SYSTEM WAS FIRST POWERED UP. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150523 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-42 N/A 00886874119716

    Patients

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