BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21979559 · Received May 7, 2025

    Report

    Report Number
    2955842-2025-17914
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 8, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. BASED ON THE FIELD EVALUATION, THE CUSTOMER REPORTED ISSUE COULD NOT BE REPRODUCED. THE FSE TESTED THE SYSTEM FOR AN HOUR. THE FANS ON THE ARMS WERE FUNCTIONING NORMAL. THE FSE DID NOT FIND THE ARMS TO BE WARM AND INSTRUCTED THE CUSTOMER TO ENSURE THE DRAPES WERE ONLY COVERING THE ARMS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, UNIVERSAL SURGICAL MANIPULATORS (USM) #2 AND #3 WERE OVERHEATING. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS FROM THAT DAY, BUT THEY WERE NOT AVAILABLE. THE TSE CONFIRMED THE CUSTOMER HAD THE USMS DRAPED AND COVERED PRIOR TO USING THE SYSTEM AND THEN THE MESSAGE APPEARED. THE TSE RECOMMENDED NOT COVERING THE USMS FOR AN EXTENDED PERIOD OF TIME PRIOR TO USE AND RECOMMENDED TRYING TO FLUFF THE DRAPES TO INCREASE AIRFLOW. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CASE WAS NOT CONVERTED TO OPEN DUE TO OVERHEATING. THE OVERHEATING MESSAGE OCCURRED WHILE THE DOCTOR WAS PUTTING TROCARS IN AND THE PORTS HAD BEEN PLACED. THE CUSTOMER HAD NOT EVEN DOCKED THE ROBOT YET. THE CUSTOMER ELECTED TO CONVERT THE CASE TO OPEN SURGERY FOR UNSPECIFIED ANATOMICAL REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132287 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-57 N/A 00886874110720

    Patients

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