BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 19472608 · Received June 5, 2024

    Report

    Report Number
    2955842-2024-15182
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 9, 2024
    Report Date
    May 9, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. FSE REPRODUCED THE ERRORS ON THE UNIVERSAL SURGICAL MANIPULATOR (USM). FSE REPLACED THE 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 (ERROR 319) WAS CONFIRMED VIA THE ERROR LOGS AND REPLICATED IN-HOUSE. THE SITE'S LOGS SHOWED A 319-ERROR OCCURRING ON USM 2 AND MULTIPLE COMMUNICATIONS ERRORS POINTING TOWARD THE AXES CONTROLLER, CARRIAGE (ACC). THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED A 307-ERROR POINTING TOWARD THE AXIS CONTROLLER CARRIAGE (ACC) BOARD. THE UNIT WAS ALSO TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED THE CHECK ALL BOARDS PRESENT TEST WHERE THE ACC BOARD WAS NOT FOUND. DURING THE INVESTIGATION, IT WAS NOTICED THAT THE ROLLING LOOP FIBER AND GROUND STRAPS WERE BROKEN AND TANGLED IN THE SPAR. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE 319 ERRORS ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AFTER DOCKING. THE CUSTOMER CONVERTED THE PROCEDURE TO LAPAROSCOPIC SURGERY BEFORE CALLING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822827 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-33 N/A 00886874115404

    Patients

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