BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22173500 · Received June 10, 2025

    Report

    Report Number
    2955842-2025-24379
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 22, 2025
    Report Date
    May 22, 2025
    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
    FL, US
    Reporter Occupation
    NURSE
    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 WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL INC. (ISI) RECEIVED THE IESU FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND THE LOG REVIEWS SHOWED ((B)(6) M-32/M-12/M-36 ERRORS (B)(6) 2025.) VISUAL INSPECTION: (THE UNIT HAS NO SIGNIFICANT SCRATCHES OR DENTS.) THE FRONT BEZEL WAS IN DECENT CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GYNECOLOGY HYSTERECTOMY BENIGN SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT THE SITE HAD RELEASE ACTIVATION SWITCH MESSAGE ALONG WITH M-10 ERROR. TSE VIEWED LOGS AND CONFIRMED ERROR M-02, M-12, AND M-10 ERRORS. THE CUSTOMER STATED THAT THE ISSUE OCCURRED PREVIOUSLY AND CONFIRMED THAT NOTHING WAS ACTIVATING THE PEDALS IN THE DRAWER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333403 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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