BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23652776 · Received November 25, 2025

    Report

    Report Number
    2955842-2025-46174
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 25, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT SUFFERED AN UNSPECIFIED POST-OPERATIVE INFECTION. THE INITIAL DA VINCI-ASSISTED SURGICAL PROCEDURE WAS COMPLETED AS PLANNED. THE FOLLOWING INFORMATION IS UNKNOWN: THE SOURCE, TYPE, CAUSE, AND SEVERITY OF THE INFECTION, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. THE HOSPITAL IS INVESTIGATING THE ROOT CAUSE OF THE INFECTIONS. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948123 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

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