BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24706727 · Received March 26, 2026

    Report

    Report Number
    2955842-2026-18911
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    May 12, 2025
    Report Date
    March 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    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 INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE AXES CONTROLLER PLATFORM (ACP) AND ACP BACKPLANE (ACPB) ON THE PATIENT SIDE CART TO CORRECT THE REPORTED PROBLEM. 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 ACP AND ACPB WERE ANALYZED AND BOTH SUBCOMPONENTS WERE FOUND TO HAVE ELECTRICAL/FIBEROPTIC DEFECTS RESULTING IN THE COMPONENTS NOT FUNCTIONING DURING TESTING. 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 AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SERVICE ENGINEER (TSE) FOR PHONE ASSISTANCE REGARDING REPEATED RECOVERABLE FAULT 32101 OCCURRING ON THE PATIENT SIDE CART (PSC). TSE HAD THE CUSTOMER SHUTDOWN THE SYSTEM, PRESS EMERGENCY POWER OFF (EPO), AND A POWER CYCLE, THE CUSTOMER STATED THAT WHEN PULLING THE RED LEVER INTO MANUAL DRIVE, THE PSC WOULD NOT MOVE. TSE REVIEWED THE SYSTEM LOGS AND FOUND PROBLEM ON THE ACP. ACPB, OR THE HYDRAULIC SYSTEM. THE CUSTOMER WAS UNABLE TO WORK WITH THE SYSTEM , AND THE NEXT SURGICAL PROCEDURE IN THE MORNING HAS BEEN CANCELLED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304341 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1