BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22947281 · Received September 2, 2025

    Report

    Report Number
    2955842-2025-36526
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 13, 2025
    Report Date
    August 13, 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
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS STARTED THAT DAY WITH A DOUBLE SURGEON SIDE CONSOLE (SSC) SETUP. MEDICAL TECHNOLOGY USED COMPRESSED AIR TO CLEAN THE BLUE FIBER OPTIC CABLE. THE SYSTEM WAS THEN RESTARTED. THIS PROCEDURE RECTIFIED THE FAULT. THE SURGERY WAS THEN COMPLETED ROBOTICALLY WITH ONE SSC. THE PROCEDURE PERFORMED WAS LYMPHADENECTOMY. THE ENTIRE SYSTEM FUNCTIONED WITHOUT COMPLICATIONS ACCORDING TO THE MEDICAL TECHNOLOGY PROCEDURE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGICAL SURGICAL PROCEDURE, A NURSE CALLED IN TO REPORT RECOVERABLE FAULTS 54 AND 40 ON THE VISION SIDE CART (VSC). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS AND CONFIRMED A BLUE FIBER CABLE (BFC) ISSUE ON THE BOTTOM CORE PORT. THE PROCEDURE WAS CONTINUING WITH THE SURGEON SIDE CONSOLE (SSC) 2. THE TSE ADVISED COMPLETING THE PROCEDURE AND CLEANING THE BFC BETWEEN SSC 1 AND VSC WHEN THE SYSTEM WAS SHUT DOWN. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2412349 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-29 N/A 00886874110744

    Patients

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