BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20880192 · Received December 9, 2024

    Report

    Report Number
    2955842-2024-22619
    Event Type
    Injury
    Date Received
    December 9, 2024
    Date of Event
    June 26, 2024
    Report Date
    November 11, 2024
    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
    CH
    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, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. CITATION: JIN, W., ZHENG, L., FAN, X. ET AL. A COMPARISON OF THREE-PORT AND FOUR-PORT DA VINCI ROBOT-ASSISTED THORACOSCOPIC SURGERY FOR LUNG CANCER: A RETROSPECTIVE STUDY. J CARDIOTHORAC SURG 19, 377 (2024). HTTPS://DOI.ORG/10.1186/S13019-024-02920-7. FIELD B3: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED DATE HAS BEEN USED. SECTION D - SUSPECT MEDICAL DEVICE: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS USED. ..

    Description of Event or Problem · 0

    A LITERATURE ARTICLE THAT DESCRIBED A RETROSPECTIVE STUDY THAT COMPARED THE OUTCOMES OF THREE-PORT AND FOUR-PORT DA VINCI-ASSISTED THORACOSCOPIC SURGERY FOR RADICAL DISSECTION OF LUNG CANCER FROM JANUARY 2020 TO OCTOBER 2021 IN ONE SINGLE INSTITUTION. 171 PATIENTS WERE INCLUDED AND MAJORITY OF THE PATIENTS UNDERWENT LOBECTOMY IN BOTH GROUPS. THE PROCEDURES WERE COMPLETED USING THE XI SYSTEM, AND DISSECTION WAS PERFORMED USING THIRD PARTY ENDO-GIA STAPLERS. THERE WAS NO CONVERSION TO THORACOTOMY, AND NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED IN THE ARTICLE. POST-OPERATIVELY, ONE PATIENT IN THE THREE-PORT GROUP AND ONE PATIENT IN THE FOUR-PORT GROUP DEVELOPED PULMONARY INFECTIONS. PULMONARY AIR LEAKAGE WAS THE MOST COMMON COMPLICATION, AFFECTING THREE PATIENTS IN THE THREE-PORT GROUP AND FOUR PATIENTS IN THE FOUR-PORT GROUP. THE ARTICLE MENTIONED THAT THE POTENTIAL CAUSE OF THE AIR LEAKAGE COULD DUE TO STAPLER FAULTS AND SEVERE POSTOPERATIVE COUGHS. THERE WERE SOME MAJOR COMPLICATIONS THAT WERE ASSESSED AS CLAVIEN-DINDO GREATER THAN GRADE 3, WHICH INCLUDES ONE PATIENT EXPERIENCED CHYLOTHORAX IN THE FOUR-PORT GROUP, ONE PATIENT EXPERIENCED PULMONARY EMBOLUS IN THE THREE-PORT GROUP, AND TWO PATIENTS EXPERIENCED OBVIOUS SUBCUTANEOUS EMPHYSEMA OR PNEUMOTHORAX IN EACH GROUP. ALL THESE PATIENTS RECOVERED WITH CONSERVATIVE TREATMENTS WITHOUT REQUIRING REOPERATION. THE DESIGNATED AUTHOR WAS CONTACTED, AND IT WAS CONFIRMED THAT THE COMPLICATIONS WERE NOT CAUSED BY THE DA VINCI DEVICES. NO DA VINCI STAPLERS WERE USED IN THE PROCEDURE WITH THE AIR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97661 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

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