BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24502976 · Received March 3, 2026

    Report

    Report Number
    2955842-2026-14653
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 3, 2026
    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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. ADDITIONAL PATIENT INFORMATION: HEIGHT 175 CM., BODY MASS INDEX (BMI) 35.3 KG/M2.

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED BENIGN HYSTERECTOMY AND SALPINGO-OOPHORECTOMY PROCEDURE. DURING THE PROCEDURE, A LEFT-SIDED URETERAL INJURY WITH URINOMA OCCURRED. AN ALLIUM URETERAL STENT AND A DOUBLE-J CATHETER (STENT-IN-STENT) WERE PLACED ON THREE DAYS LATER, AND THE PATIENT WAS STARTED ON ANTIBIOTICS (AMPICILLIN/SULBACTAM). NO SPECIFIC INSTRUMENT WAS INVOLVED IN THE INJURY; TRACTION OR STRETCHING OF THE URETER SEEMS TO BE THE MOST LIKELY REASON. PROLONGED HOSPITALIZATION WAS REPORTED. THE EVENT WAS DEEMED RESOLVED FOUR DAYS LATER; DISCHARGE TO HOME OCCURRED THE SAME DAY. IT WAS REPORTED THAT THERE WERE NO INTRA-OPERATIVE DEVICE DEFICIENCIES. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MODERATE, A SERIOUS ADVERSE EVENT (REQUIRING MEDICAL OR SURGICAL INTERVENTION), AN OSLO CLASSIFICATION GRADE II, PROBABLY RELATED TO THE STUDY PROCEDURE, BUT NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, NOT RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE, AND NOT RELATED TO A THIRD-PARTY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562189 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES