BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21458880 · Received February 25, 2025

    Report

    Report Number
    2955842-2025-01994
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    January 29, 2025
    Report Date
    January 29, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. FSE CONDUCTED A TEST DRIVE OF THE SYSTEM AND COULD NOT REPRODUCE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED UNIVERSAL SURGICAL MANIPULATOR (USM) #2, LED WAS YELLOW AND COULD NOT ADVANCE WELL. IT WAS STATED THAT THE CASE WAS COMPLETED BY SWITCHING TO USM #4 INSTEAD. TSE VIEWED LOGS BUT DID NOT FIND ANY RELATED ERRORS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PORTS WERE PLACED PRIOR TO ISSUE BEING IDENTIFIED. SURGEON ELECTED NOT TO USE ARM #2 (NON-WORKING ARM) IN ORDER TO PROCEED WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH 3-ARMS USED DUE TO ARM #2 NOT COMMUNICATING WELL WITH SURGEON'S CONSOLE AND THE LIGHT ON ARM #2 WAS ORANGE. ALSO, THE PHYSICIAN ASSISTANT COULD NOT ADVANCE ROBOTIC ARM INTO THE TROCAR. PROCEDURE WAS COMPLETED ROBOTICALLY WITH ARMS #1, 3, AND 4. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411538 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-55 N/A 00886874110720

    Patients

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