BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23750916 · Received December 8, 2025

    Report

    Report Number
    2955842-2025-47091
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    April 30, 2025
    Report Date
    December 8, 2025
    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
    UK
    Reporter Occupation
    003

    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. CITATION: MCNICHOLAS, D.P., KATTAKAYAM, F., THOMPSON, T. ET AL. ROBOTIC RETROPERITONEAL LYMPH-NODE DISSECTION FOR TESTICULAR CANCER: INITIAL EXPERIENCE. J ROBOTIC SURG 19, 190 (2025). HTTPS://DOI.ORG/10.1007/S11701-025-02322-4. PATIENT AGE: REFLECTS THE STUDY MEAN AGE WAS 36 (RANGE 18¿68). PATIENT GENDER IS SELECTED AS MALE, AS ALL PATIENTS WERE MALE. PAST MEDICAL HISTORY IS UPDATED, AS ALL PATIENTS IN THE COHORT HAS TESTICULAR CANCER. SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH REPORT (MDR) SUBMISSION TO THE FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE SURGICAL, INC. (ISI) WAS 10-NOV-2025.

    Description of Event or Problem · 0

    A REVIEW OF A LITERATURE ARTICLE WAS PERFORMED. CASES WERE RETROSPECTIVELY ANALYZED TO IDENTIFY PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED RETROPERITONEAL LYMPH-NODE DISSECTION (RA-RPLND) FROM APRIL 2021 TO JULY 2024. THERE WERE A TOTAL OF 24 PATIENTS WHO UNDERWENT A RA-RPLND WITH THE DA VINCI XI SYSTEM AT ONE SITE. THE MEAN AGE WAS 36 (RANGE 18¿68). THE ARTICLE NOTED THAT DURING THE DA VINCI-ASSISTED SURGERIES, ONE PATIENT REQUIRED A BLOOD TRANSFUSION AND THIS SAME PATIENT WAS THE ONLY CONVERSION TO OPEN SURGERY, WHICH WAS SECONDARY TO BLEEDING FROM THE LEFT RENAL VEIN. THERE WERE NO PERI-OPERATIVE DEATHS. ANOTHER PATIENT, WITHIN 90 DAYS OF UNDERGOING SURGERY, WAS READMITTED FOR A CHYLE LEAK. THE COMPLICATION WAS MANAGED CONSERVATIVELY. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858541 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES