BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 25322546 · Received May 28, 2026

    Report

    Report Number
    2955842-2026-25983
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    June 18, 2025
    Report Date
    May 4, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. IMAGES ASSOCIATED WITH THIS REPORTED EVENT WERE INCLUDED IN THE ARTICLE. CITATION: GIANNINI A, VIZZA E, BRUNO V, ET AL. ROBOTIC-ASSISTED SINGLE-PORT AND MULTI-PORT SURGICAL STAGING IN EARLY-STAGE ENDOMETRIAL CANCER: A PROPENSITY-MATCHED COMPARISON. EUR J SURG ONCOL. 2025;51(9):110269. DOI:10.1016/J.EJSO.2025.06.697 SECTION A2: PATIENT INFORMATION AGE - REFLECTS THE STUDY MEAN AGE OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION A3A: PATIENT GENDER REPRESENTS THE MAJORITY OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION B7: MEDICAL HISTORY REFLECTS THE STUDY POPULATION CO-MORBIDITIES, NOT THE SPECIFIC PATIENT. SECTION D: GENERIC DA VINCI XI SYSTEM PRODUCT INFORMATION NUMBER IS PROVIDED. SECTION E: THE EVENT SITE IS RECORDED BASED ON THE LOCATION OF THE FIRST AUTHOR'S ASSOCIATED HOSPITAL. WHILE THE EXACT SITE IS UNKNOWN, THIS DESIGNATION IS CONSIDERED AN APPROPRIATE SUBSTITUTION. SECTION E: SINCE THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY INTUITIVE SURGICAL, INC. (ISI) RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT.

    Description of Event or Problem · 0

    A REVIEW OF AN ARTICLE THAT EVALUATED THE SAFETY AND PERIOPERATIVE OUTCOMES OF ROBOTIC-ASSISTED SINGLE-PORT VERSUS MULTI-PORT SURGICAL STAGING FOR APPARENT EARLY-STAGE ENDOMETRIAL CANCER WAS PERFORMED. THE RETROSPECTIVE, PROPENSITY-MATCHED STUDY ANALYZED 100 PATIENTS UNDERGOING ROBOTIC-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND NODAL STAGING USING THE DA VINCI SURGICAL SYSTEM BETWEEN JANUARY 2021 AND DECEMBER 2024. A TOTAL OF 3 PATIENTS IN THE SINGLE-PORT GROUP EXPERIENCED POSTOPERATIVE COMPLICATIONS WITHIN 30 DAYS, INCLUDING SURGICAL SITE INFECTION AND ABDOMINAL PAIN REQUIRING READMISSION, AND HEMOPERITONEUM REQUIRING SURGICAL RE-INTERVENTION. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY INTUITIVE SURGICAL, INC. (ISI) DEVICE. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE AUTHOR. NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602449 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1