BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21566954 · Received March 10, 2025

    Report

    Report Number
    2955842-2025-02184
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    February 13, 2025
    Report Date
    February 13, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED, ALTHOUGH THE CUSTOMER ATTRIBUTED THE EVENT TO SURGICAL TECHNIQUE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MEDIASTINAL MASS RESECTION PROCEDURE, BLEEDING FROM THE AORTA NECESSITATED CONVERSION TO AN OPEN PROCEDURE AND RESULTED IN THE PATIENT BEING PLACED ON CARDIOPULMONARY BYPASS (CPB). THE BLEEDING OCCURRED FOLLOWING THE RESECTION OF THE MEDIASTINAL TUMOR. THE CAUSE AND EXTENT OF THE BLOOD LOSS WERE UNKNOWN; HOWEVER, DUE TO THE SEVERITY OF BLEEDING, AN EMERGENCY ROLLOUT WAS SUCCESSFULLY PERFORMED, AND THE PROCEDURE WAS CONVERTED TO OPEN TO ADDRESS THE BLEEDING AND ACHIEVE HEMOSTASIS. COMPRESSION WAS APPLIED AT THE BLEEDING SITE, AND A CARDIAC SURGEON WAS REQUIRED TO PLACE THE PATIENT ON CPB. THE PATIENT IS STILL UNDER OBSERVATION AND IN STABLE CONDITION. THE SURGEON DOES NOT BELIEVE THAT ANY MALFUNCTION OF AN INTUITIVE SURGICAL INC. (ISI) SYSTEM, INSTRUMENT, OR ACCESSORY CONTRIBUTED TO THE EVENT; IT WAS ATTRIBUTED TO SURGICAL TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031539 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization| R| L DA VINCI INSTRUMENTS AND ACCESSORIES.