BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21934456 · Received April 30, 2025

    Report

    Report Number
    2955842-2025-17350
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    September 20, 2024
    Report Date
    April 3, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. CITATION: WINTER, M., ET AL. (2024). SUBCUTANEOUS EMPHYSEMA IN PATIENTS UNDERGOING ROBOTIC CARDIAC SURGERY: RISK FACTORS AND CLINICAL OUTCOME. JOURNAL OF ROBOTIC SURGERY, 18(1). HTTPS://DOI.ORG/10.1007/S11701-024-02112-4. INTUITIVE SURGICAL INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 0

    A REVIEW OF A LITERATURE ARTICLE 'SUBCUTANEOUS EMPHYSEMA IN PATIENTS UNDERGOING ROBOTIC CARDIAC SURGERY: RISK FACTORS AND CLINICAL OUTCOME¿ WAS PERFORMED. A TOTAL OF 121 PATIENTS WHO UNDERWENT ROBOTIC CARDIAC SURGERY DURING THE TIMEFRAME OF JULY 2021 TO JULY 2023 WERE CONSIDERED FOR THIS STUDY. OF THESE, 63 PATIENTS (54.3%) UNDERWENT ROBOTICALLY ASSISTED MITRAL VALVE REPAIR. THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, COMPLICATIONS, SUCH AS, SUBCUTANEOUS EMPHYSEMA (SE) WERE REPORTED. WHILE THE DOCUMENT DOES NOT EXPLICITLY ASSOCIATE SE WITH THE ROBOT ITSELF, IT HIGHLIGHTS FACTORS SUCH AS THE USE OF LARGER PORTS (8 MM) AND LONGER PROCEDURE TIMES IN ROBOTIC CARDIAC SURGERY, WHICH MAY CONTRIBUTE TO THE HIGHER INCIDENCE OF SE. ADDITIONALLY, SE WAS MORE COMMON IN ROBOTIC MITRAL VALVE REPAIR COMPARED TO ROBOTIC CORONARY BYPASS PROCEDURES, POTENTIALLY DUE TO INCREASED LUNG MANIPULATION REQUIRED FOR MITRAL VALVE ACCESS. OTHER SIGNIFICANT REPORTED POST PROCEDURE COMPLICATIONS INCLUDED PNEUMONIA, PNEUMOTHORAX, AND CONVERSION TO STERNOTOMY. APPROXIMATELY ONE OUT OF FIVE PATIENTS WITH SEVERE SE REQUIRED ADDITIONAL THORACIC DRAINAGE IN ADDITION TO AN INCREASED NEED FOR COMPUTED TOMOGRAPHY (CT) IMAGING. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369507 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES