BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25340075 · Received May 29, 2026

    Report

    Report Number
    2955842-2026-26991
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 29, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 REPLACED INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. THE GENERATOR UNIT WAS RETURNED FOR FAILURE ANALYSIS WITH THE REPORTED ISSUE, AND THE CONDITION COULD NOT BE CONFIRMED THROUGH LOGS. FUNCTIONAL TESTING REVEALED THAT THE UNIT POWERED ON NORMALLY AND SUCCESSFULLY CAUTERIZED ACROSS ALL PORTS AND INSTRUMENTS WITHOUT ISSUE LOG SHOWED ERRORS M-0B AND M-B0.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SERVICE ENGINEER (TSE) FOR PHONE ASSISTANCE REGARDING AUDIO FEEDBACK THAT WAS BEING HEARD AT THE PATIENT SIDE CART (PSC) AND THE SURGEON SIDE CONSOLE (SSC) WHEN ENERGY WAS BEING APPLIED. IT WAS NOTED THAT THE REPORTED EVENT WAS ONLY PRESENT WITH ONE SURGEON; HOWEVER, THE CSR COULD HEAR THE FEEDBACK WHEN STANDING NEXT TO THE SURGEON SIDE CONSOLE. TSE REVIEWED THE SYSTEM LOGS AND FOUND NO RELATED ERRORS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271086 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1