BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23408224 · Received October 28, 2025

    Report

    Report Number
    2955842-2025-43267
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 7, 2025
    Report Date
    November 20, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER USED SURGEON CONSOLE 1 TO CONTINUE THE PROCEDURE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE REMAINING SURGEON SIDE CONSOLE 1. CUSTOMER WAS NOT ABLE TO REGAIN CONTROL OF THE SURGEON SIDE CONSOLE 2 AT ANY POINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT SURGEON SIDE CONSOLE (SSC) 2 COULD NOT CONTROL UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AFTER THE CUSTOMER ASSIGNED USM 1 TO SSC 2. THE SURGEON WAS ABLE TO CONTINUE THE PROCEDURE WITH SSC 1 WITHOUT ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587872 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-21 N/A 00886874110744

    Patients

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