BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23195361 · Received October 1, 2025

    Report

    Report Number
    2955842-2025-40184
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 11, 2025
    Report Date
    September 11, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE WAS UNABLE TO DUPLICATE THE ISSUES, BUT DUE TO THE RECENT CONSISTENT PROBLEMS WITH THE ROBOT, REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM3). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE USM3.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INDICATED THE UNIVERSAL SURGICAL MANIPULATOR (USM3) WOULD NOT ADVANCE COMPLETELY DOWN. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO PERFORM AN EMERGENCY STOP (ESTOP) AND RECOVER; HOWEVER, THE CUSTOMER DECIDED TO COMPLETE THE CURRENT CASE AND WOULD SWITCH TO ANOTHER SYSTEM FOR THE NEXT CASE. THE PATIENT SIDE CART (PSC) WAS CONNECTED TO THE VISION SIDE CART (VSC). THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316312 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A

    Patients

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