BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19828146 · Received July 25, 2024

    Report

    Report Number
    2955842-2024-17235
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 28, 2024
    Report Date
    June 28, 2024
    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
    VA, US
    Reporter Occupation
    PHYSICIAN
    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 REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED VIA THE ERROR LOGS AND REPLICATED IN-HOUSE. THE SITE'S LOGS SHOWED MULTIPLE 319 ERRORS WHERE IT SHOWS NODES AXES CONTROLLER SPAR (ACS) AND AXES CONTROLLER, CARRIAGE (ACC) NOT FOUND. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED A 319. THE UNIT WAS ALSO TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED THE CHECK ALL BOARDS PRESENT (NODES ACS AND ACC NOT FOUND) AND FIBER TEST ON THE PARALLELOGRAM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, WHILE TROUBLESHOOTING ANOTHER ISSUE FOR THE SYSTEM AND POWER CYCLING, AN ERROR 319 APPEARED. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED ERROR 319 ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1. THE TSE INSTRUCTED THE CUSTOMER TO POWER CYCLE THE SYSTEM AND HARD POWER CYCLE THE PATIENT SIDE CART (PSC) BUT THE ISSUE RETURNED EACH TIME. THE CUSTOMER NEEDED ALL FOUR USMS FOR THE PROCEDURE AND OPTED TO CONVERT THE PROCEDURE TO LAPAROSCOPY. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302000 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES