BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22046191 · Received May 19, 2025

    Report

    Report Number
    2955842-2025-20675
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    April 22, 2025
    Report Date
    April 22, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF ANY MALFUNCTION OF AN INTUITIVE SURGICAL INC. (ISI) SYSTEM, INSTRUMENT OR ACCESSORY OCCURRING DURING THE PROCEDURE; THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND THE INVESTIGATION 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 DA VINCI-ASSISTED MEDIASTINAL MASS RESECTION PROCEDURE, AN UNSPECIFIED AMOUNT OF UNEXPECTED BLEEDING OCCURRED. THE BLEEDING OCCURRED DURING TUMOR DISSECTION, ORIGINATING FROM AN UNIDENTIFIED TISSUE OR VESSEL. THE SURGEON DOES NOT THINK THAT A DA VINCI SYSTEM, INSTRUMENT, AND/OR ACCESSORY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE AMOUNT OF BLEEDING OR WHETHER THE PATIENT REQUIRED A TRANSFUSION REMAINS UNKNOWN. TO CONTROL THE BLEEDING, COMPRESSION WAS APPLIED, AND THE PROCEDURE APPROACH WAS CONVERTED TO OPEN SURGERY. SPECIFIC INFORMATION ON HOW THE BLEEDING WAS RESOLVED WAS NOT PROVIDED. A CARDIAC SURGEON WAS INVOLVED IN THE PROCEDURE AFTER THE BLEEDING OCCURRED AND DETERMINED THAT THE TUMOR ORIGINATED FROM THE CARDIAC REGION RATHER THAN THE MEDIASTINUM. THE PROCEDURE WAS COMPLETED, AND IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY POST-OPERATIVE COMPLICATIONS, ALTHOUGH THE PATIENT STATUS WAS NOTED AS "NO PROBLEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129628 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES