BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20675793 · Received November 13, 2024

    Report

    Report Number
    2955842-2024-21798
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    May 10, 2024
    Report Date
    October 18, 2024
    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
    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 DATES 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: WANG, J., ZHOU, J., ZHAO, S. ET AL. ROBOTIC VERSUS LAPAROSCOPIC ANTERIOR RESECTION FOR THE TREATMENT OF STAGE II AND III SIGMOID COLON CANCER: A PROPENSITY SCORE-MATCHED ANALYSIS. J ROBOTIC SURG 18, 207 (2024). HTTPS://DOI.ORG/10.1007/S11701-024-01967-X. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. THE MEDIAN AGE ROBOTIC GROUP IS 58 YEARS; THE MAJORITY (51%) OF PATIENTS WERE MALE. SECTION 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.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY INVOLVING PATIENTS DIAGNOSED WITH SIGMOID COLON CANCER WHO UNDERWENT ANTERIOR RESECTION BETWEEN JANUARY 2019 AND SEPTEMBER 2023 IN ONE SINGLE INSTITUTION. THE AIM OF THIS STUDY WAS TO COMPARE THE OUTCOMES OF ROBOT-ASSISTED LAPAROSCOPIC SURGERY (RLS) VERSUS CONVENTIONAL LAPAROSCOPIC SURGERY (CLS) IN RELATION TO THE TREATMENT OF SIGMOID COLON CANCER. A TOTAL OF 212 PATIENTS WERE INCLUDED IN THE STUDY, 106 PATIENTS IN THE RLS GROUP AND 106 IN THE CLS GROUP. IN THE DA VINCI-ASSISTED GROUP(I.E. RAS), THE FOLLOWING COMPLICATIONS WERE NOTED: CONVERSION TO OPEN SURGERY OCCURRED IN 2 PATIENTS, WOUND INFECTION IN 3 PATIENTS, PULMONARY INFECTION IN 4 PATIENTS, CLAVIEN-DINDO GRADE III¿IV COMPLICATIONS IN 1 PATIENT, AND POSTOPERATIVE BLEEDING IN 1 PATIENT. NO SPECIFIC DETAILS OF THE COMPLICATIONS AND PATIENTS INVOLVED WERE PROVIDED. NO DA VINCI DEVICE ISSUES WERE MENTIONED IN THE ARTICLE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ARTICLE CORRESPONDENCE. PER THE ARTICLE CORRESPONDENCE, THERE WERE NO DA VINCI DEVICE MALFUNCTIONS AND NO DA VINCI PRODUCTS CAUSED OR CONTRIBUTED TO THE COMPLICATIONS MENTIONED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421466 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES