BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24810075 · Received April 7, 2026

    Report

    Report Number
    2955842-2026-20745
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 7, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED FOOT PEDAL TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS NOT RECEIVED THE FOOT PEDAL FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED AN ISSUE WHERE THE BIPOLAR WAS ACTIVATED UNINTENTIONALLY WITH THE BIPOLAR PEDAL IN THE VISION SIDE CART (VSC) DRAWER, AND M-12 ERRORS REPEATED DURING MONOPOLAR ACTIVATION. THE CUSTOMER NOTED THAT BARELY TOUCHING THE BIPOLAR PEDAL ACTIVATED THE BIPOLAR FUNCTION. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO DISCONNECT THE BIPOLAR FOOT SWITCH CABLE, WHICH CLEARED THE ERROR. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THERE WAS NOT ANY UNINTENDED TISSUE DAMAGE AS A RESULT OF THE AUTO FIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479236 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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