BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 22645095 · Received July 29, 2025

    Report

    Report Number
    2955842-2025-31854
    Event Type
    Injury
    Date Received
    July 29, 2025
    Date of Event
    July 8, 2025
    Report Date
    July 9, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    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 AFTER A DA VINCI-ASSISTED VALVE REPAIR PROCEDURE, THE PATIENT EXPERIENCED A CARDIAC TAMPONADE SECONDARY TO AN AORTIC RUPTURE, WHICH REQUIRED AN ADDITIONAL SURGICAL PROCEDURE. THE AORTIC RUPTURE WAS IDENTIFIED AFTER THE PATIENT DEVELOPED A SUDDEN ONSET OF HYPOTENSION WHILE BEING TRANSFERRED FROM THE OPERATING ROOM BED TO A STRETCHER. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A CARDIAC TAMPONADE. AN EMERGENCY THORACOTOMY WAS PERFORMED TO ACCESS THE HEART. UPON OPENING THE PERICARDIUM, THE AORTIC RUPTURE WAS IDENTIFIED AT THE CARDIOPLEGIA PUNCTURE SITE. DUE TO LIMITED ACCESS TO THE LESION, BOTH A MEDIAN THORACOTOMY AND A MEDIAN STERNOTOMY WERE PERFORMED TO GAIN ADEQUATE EXPOSURE. THE AORTIC LESION WAS RESOLVED VIA A TWO-LAYER AORTORRHAPHY USING 4-0 PROLENE SUTURE, AND THE SUTURE LINE WAS REINFORCED WITH BIOLOGICAL GLUE. THE PATIENT WAS MONITORED INTRAOPERATIVELY FOR APPROXIMATELY 15 MINUTES, DURING WHICH CEREBRAL HYPOPERFUSION OCCURRED, REQUIRING CARDIAC MASSAGE AND FLUID RESUSCITATION. ADEQUATE CEREBRAL PERFUSION WAS ACHIEVED, AND MULTIPLE BLOOD TRANSFUSIONS WERE ADMINISTERED TO STABILIZE THE PATIENT HEMODYNAMICALLY. AFTER ACHIEVING THOROUGH HEMOSTASIS, THE PLEURA AND MEDIASTINUM SPACES WERE DRAINED. PACEMAKER WIRES WERE PLACED IN THE RIGHT VENTRICLE, AND THE STERNUM WAS CLOSED USING 5-GAUGE STEEL WIRES. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS TRANSFERRED TO THE ICU FOR CONTINUED MONITORING. THE SURGEON DOES NOT BELIEVE THAT A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT¿S CURRENT CONDITION REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886777 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-47 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention| H| L DA VINCI INSTRUMENTS AND ACCESSORIES