BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 22722961 · Received August 5, 2025

    Report

    Report Number
    2955842-2025-33066
    Event Type
    Death
    Date Received
    August 5, 2025
    Report Date
    July 14, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO STATEMENT OF ANY MALFUNCTION OF AN INTUITIVE SURGICAL INC. (ISI) SYSTEM, INSTRUMENT OR ACCESSORY OCCURRING DURING THE PROCEDURE. NO PRODUCT IS EXPECTED TO BE RETURNED. THE PROCEDURE DATE, TIME AND SURGEON WERE NOT PROVIDED. THEREFORE, NO DA VINCI SYSTEM LOGS ARE AVAILABLE FOR REVIEW. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT IN THIS REPORT DIED FOLLOWING AN UNSPECIFIED COLORECTAL PROCEDURE. NO ADDITIONAL DETAILS ARE PROVIDED. BASED ON THE INFORMATION IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED COLORECTAL PROCEDURE, THE PATIENT EXPIRED; HOWEVER, THE CAUSE OF DEATH WAS NOT DISCLOSED. THE INTUITIVE CLINICAL SALES REPRESENTATIVE WAS INFORMED OF ¿OVERHEARD INFORMATION¿ IN THE HOSPITAL ABOUT THE PATIENT DEATH. ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, THE SITE HAS CONFIRMED THAT NO FURTHER DETAILS WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377846 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

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