BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 23652774 · Received November 25, 2025

    Report

    Report Number
    2955842-2025-46176
    Event Type
    Injury
    Date Received
    November 25, 2025
    Report Date
    November 25, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    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 INFECTION. 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
    1948121 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-42 N/A 00886874119716

    Patients

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