BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18564897 · Received January 23, 2024

    Report

    Report Number
    2955842-2024-10493
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    January 2, 2024
    Report Date
    January 2, 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
    UK
    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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED PROBLEM. THE FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) 3 DUE TO ERROR 319. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE ISI DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED ERRORS AS HAVING OCCURRED IN THE FIELD VIA SYSTEM LOGS AND WAS REPLICATED IN-HOUSE. THE SYSTEM LOGS SHOWED AN ERROR 319 POINTING TOWARDS THE AXES CONTROLLER, CARRIAGE (ACC). THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED AN ERROR 319. THE USM WAS ALSO TESTED ON THE PATIENT SIDE CART PSC FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED CHECK ALL BOARDS PRESENT (AC NOT FOUND) AND FIBER TEST ON ROLLING LOOP. A GOLDEN ROLLING LOOP FIBER WAS INSTALLED AND CHECK ALL BOARDS PRESENT AND FIBER TEST PASSED. ALL OTHER TESTS PASSED ON RETRY. DURING INVESTIGATION, IT WAS NOTICED THAT THE ROLLING LOOP FIBER AND GROUND STRAPS WERE TANGLED IN THE SPAR. AS A FIX, THE ROLLING LOOP FIBER ASSEMBLY WILL BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THEY GOT A NON-RECOVERABLE ERROR 319 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THEY HAD RESTARTED THE SYSTEM, BUT THE ISSUE PERSISTED. THEY WERE ABLE TO DISABLE USM 3. THE ISI TSE REVIEWED THE LIVE LOGS AND IDENTIFIED ERROR 319 POINTING TO A NODE NOT PRESENT, NODE NAME AXES CONTROLLER, CARRIAGE (ACC) IN ARMNET 3. THE ISI TSE ASKED THE CALLER TO PERFORM A HARD POWER CYCLE AND EMERGENCY POWER OFF (EPO), BUT THE SURGEON EXPLAINED THAT THEY HAD RESTARTED THE SYSTEM TWICE. THE SURGEON WAS ASKING IF IT WAS POSSIBLE TO ACTIVATE USM 3. THE ISI TSE EXPLAINED TO THE SURGEON THAT USM 3 WAS DISABLED, AND A FIELD SERVICE ENGINEER (FSE) VISIT WAS NEEDED. THE ISI TSE EXPLAINED HE COULD USE THE SYSTEM ONLY WITH 3 USMS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839589 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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