BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25024506 · Received April 29, 2026

    Report

    Report Number
    2955842-2026-23237
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 28, 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
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 COMPLAINT. THE FSE FOUND THIS ISSUE WAS HAPPENING INTERMITTENTLY. TO RESOLVE THE ISSUE THE FSE REPLACED THE FOLLOWING ITEMS: TWO AXES CONTROLLER PLATFORM (ACP), AXES CONTROLLER PLATFORM, AND UNIVERSAL MOTION CONTROLLER (UMC). THE TWO ACPS, AXES CONTROLLER PLATFORM, AND UMC INVOLVED WITH THIS EVENT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INTERNAL MAMMARY ARTERY HARVEST (MIDCAB) SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THEY WERE GETTING ERROR 40106. THE CUSTOMER WAS COMPLETING THE PROCEDURE BY DISABLING THE BOOM. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE TSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THERE WERE NO INJURY OR COMPLICATIONS FOR THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. NO PATIENT DEMOGRAPHICS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418387 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1