BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22170711 · Received June 9, 2025

    Report

    Report Number
    2955842-2025-23822
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 20, 2025
    Report Date
    May 20, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE FOR FURTHER ANALYSIS. DURING THE SITE VISIT, THE FSE UTILIZED AURORA COMM STATUS TO DIAGNOSE COMMUNICATION ERRORS AND EMPLOYED FIBER BYPASS TECHNIQUES TO ISOLATE COMPONENTS. THE ENGINEER RESEATED CABLES AT PROXIMAL, VERTICAL, AND HORIZONTAL LOCATIONS AND REPLACED TWO FIBER OPTIC CABLES. FOLLOWING THESE ACTIONS, THE FSE SUCCESSFULLY CLEARED COMMUNICATION ERRORS, PERFORMED SYSTEM VERIFICATION, AND CONFIRMED THE SYSTEM WAS FULLY OPERATIONAL AND READY FOR USE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE OPERATING ROOM (OR) STAFF CALLED INTO INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) MID PROCEDURE STATING THEY WERE HAVING RECOVERABLE ERRORS TWICE AND 5 MINUTES LATER TURNED INTO A NON-RECOVERABLE FAULT. THE SURGEON DID NOT WANT TO WAIT AND DECIDED TO CONVERT TO OPEN. THE SE VIEWED LOGS AND FOUND 3 ERRORS ON ARMNET 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333129 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-36 N/A 00886874110720

    Patients

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