BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23572297 · Received November 17, 2025

    Report

    Report Number
    2955842-2025-44316
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    April 11, 2025
    Report Date
    November 17, 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
    BE
    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. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO THE FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE WAS 21-OCT-2021. CITATION: HERMANS, T., SCHEVENELS, G., MOTMANS, S., DE SUTTER, T., & RASKIN, Y. (2025). STAPLED VS. MANUALLY SUTURED BOWEL ANASTOMOSIS IN ROBOT-ASSISTED RADICAL CYSTECTOMY: A SINGLE-CENTER RETROSPECTIVE ANALYSIS. BMC UROLOGY, 25(1). HTTPS://DOI.ORG/10.1186/S12894-025-01763-1.

    Description of Event or Problem · 0

    A REVIEW OF LITERATURE ARTICLE WAS CONDUCTED WHICH RETROSPECTIVELY COMPARED ROBOTIC MANUALLY SUTURED AND STAPLED BOWEL ANASTOMOSIS APPROACHES TO BETTER UNDERSTAND THEIR SAFETY, EFFICACY, AND POSTOPERATIVE OUTCOMES. THIS STUDY ANALYZED DATA OF 92 PATIENTS WHO UNDERWENT ROBOT-ASSISTED RADICAL CYSTECTOMY (RARC) AT A SINGLE HOSPITAL BETWEEN MARCH 2021 AND NOVEMBER 2023. THE ARTICLE NOTED THAT DURING THE DA VINCI SURGERIES, NON-GASTROINTESTINAL COMPLICATIONS ACCOUNTED FOR SEVERAL CASES, INCLUDING ILEO-URETERIC ANASTOMOSIS LEAKAGE (3/17) AND INFECTIONS (11/17). NOTABLY, 3 PATIENTS IN THE SUTURED GROUP DEVELOPED UROSEPSIS DUE TO OBSTRUCTIVE UROLITHIASIS, WITH ONE REQUIRING ICU ADMISSION FOR GRADE 4B COMPLICATIONS INVOLVING MULTI-ORGAN FAILURE. 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. PER THE AUTHOR, THERE WERE NO ISSUES OR COMPLICATIONS CAUSED BY ANY DA VINCI MATERIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280532 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R DA VINCI INSTRUMENTS AND ACCESSORIES.