BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22922526 · Received August 29, 2025

    Report

    Report Number
    2955842-2025-36072
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 8, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    ISIFA2023-08-C
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. D10 CONCOMITANT PRODUCTS: MONOPOLAR CURVED SCISSORS INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE CUSTOMER OBSERVED UNEXPECTED MOTION WITH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WHICH CAUSED AN INJURY TO THE EXTERNAL ILIAC ARTERY. AFTER A SUCCESSFUL HYSTERECTOMY AND DURING LYMPH NODE REMOVAL, THE SURGEON WAS USING THE MCS INSTRUMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE MCS INSTRUMENT WAS BEING USED IN A DOWNWARD MOTION, NEAR THE EXTERNAL ILIAC ARTERY. THE MCS INSTRUMENT THEN MOVED UNEXPECTEDLY UPWARD. AT THAT TIME, THE INSTRUMENT'S TIPS WERE NOT VISUALIZED AND THE EXTERNAL ILIAC ARTERY WAS INJURED. A VASCULAR AND A CARDIOVASCULAR SURGEON WERE CALLED TO THE OPERATING ROOM TO ASSIST WITH THE INJURY. THE CARDIOVASCULAR SURGEON PLACED A STENT IN THE EXTERNAL ILIAC ARTERY AND REPAIRED THE INJURY ROBOTICALLY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT IS REPORTED TO BE RECOVERING WELL. THE ESTIMATED BLOOD LOSS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130515 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.