BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20287276 · Received September 23, 2024

    Report

    Report Number
    2955842-2024-19558
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 28, 2024
    Report Date
    August 28, 2024
    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
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WOULD PERFORM A CASE OBSERVATION FOR THE REPORTED DRIFTING ISSUE. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, ONE OF THE UNIVERSAL SURGICAL MANIPULATORS (USMS) DRIFTED WHEN THE SURGEON RELEASED THE MASTER TOOL MANIPULATORS (MTMS). IT WAS NOTED THAT THE ISSUE OCCURRED ON BOTH SURGEON SIDE CONSOLES (SSCS). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND ERROR 23075 INDICATING THAT THE SURGEON RELEASED AN MTM WHILE HIS/HER HEAD WAS STILL IN THE HIGH RESOLUTION STEREO VIEWER (HRSV). HOWEVER, THIS SSC WAS BEING USED WITH ANOTHER SYSTEM (SK3359) AT THE TIME OF THE EVENT. THE SURGEON WAS ADVISED NOT TO RELEASE THE MTMS WHILE HIS/HER HEAD WAS STILL IN THE HRSV. THE TSE INFORMED THE CUSTOMER THAT A SETUP/DRAPE TENSION ISSUE COULD CAUSE AN ARM TO DRIFT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103836 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-10 N/A 00886874110744

    Patients

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