BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23556266 · Received November 14, 2025

    Report

    Report Number
    2955842-2025-44669
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    September 11, 2024
    Report Date
    November 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF ANY DA VINCI PRODUCT ISSUES, AND NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT EVENT INFORMATION. SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE SURGICAL, INC. (ISI) WAS 17-OCT-2025. CITATION: NODA, K., ET AL. (2024). TOTALLY ENDOSCOPIC ROBOTIC REPAIR OF CORONARY SINUS ATRIAL SEPTAL DEFECT WITH CONCOMITANT TRICUSPID ANNULOPLASTY. GENERAL THORACIC AND CARDIOVASCULAR SURGERY CASES, 3(42). HTTPS://DOI.ORG/10.1186/S44215-024-00167-1.

    Description of Event or Problem · 0

    A REVIEW OF AN ARTICLE TITLED, "TOTALLY ENDOSCOPIC ROBOTIC REPAIR OF CORONARY SINUS ATRIAL SEPTAL DEFECT WITH CONCOMITANT TRICUSPID ANNULOPLASTY," WAS CONDUCTED. THE ARTICLE AIMED TO DESCRIBE A RARE CASE AND EVALUATE THE FEASIBILITY OF A TOTALLY ENDOSCOPIC ROBOTIC APPROACH FOR CORONARY SINUS ATRIAL SEPTAL DEFECT REPAIR WITH CONCOMITANT TRICUSPID ANNULOPLASTY. THE STUDY WAS A SINGLE-PATIENT CASE REPORT THAT ANALYZED 1 PATIENT WHO UNDERWENT A TOTALLY ENDOSCOPIC ROBOTIC REPAIR OF A CORONARY SINUS ATRIAL SEPTAL DEFECT AND TRICUSPID ANNULOPLASTY BETWEEN 16-APR-2024 AND 30-AUG-2024. THE PATIENT EXPERIENCED POSTOPERATIVE EPISODES OF PAROXYSMAL ATRIAL FIBRILLATION REQUIRING ANTICOAGULATION THERAPY. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY #12 AND WAS CLINICALLY WELL AFTER A YEAR. THE AUTHORS CONCLUDED THAT ROBOTIC TECHNOLOGY COULD OFFER A FEASIBLE ALTERNATIVE DUE TO ITS ABILITY TO PROVIDE A HIGH-QUALITY SURGICAL VIEW OF THIS ANOMALY. PER THE AUTHOR, THERE WAS NO DEVICE MALFUNCTIONS AND NO EVENTS WERE CAUSED BY THE DA VINCI SURGICAL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2805111 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.