BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24293643 · Received February 9, 2026

    Report

    Report Number
    2955842-2026-03094
    Event Type
    Injury
    Date Received
    February 9, 2026
    Date of Event
    January 14, 2026
    Report Date
    February 9, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT THAT WAS INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1 STOPPED MOVING. AT THE TIME, TISSUE WAS STILL GRASPED IN THE INSTRUMENT'S JAWS. THE SURGEON WAS ABLE TO REGAIN CONTROL OF THE INSTRUMENT AND CONTINUED THE PROCEDURE. HOWEVER, UNINTENDED BLEEDING OCCURRED, REQUIRING UNSPECIFIED MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359061 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

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