BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19000018 · Received March 28, 2024

    Report

    Report Number
    2955842-2024-12905
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 13, 2024
    Report Date
    April 23, 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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND CONFIRMED THE REPORTED ISSUE. THE FSE REPLACED SET-UP JOINT, UNIVESAL MASTER CONTROLLER AND UNIVERSAL POWER DISTRIBUTOR TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DEVICES FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) ADVANCED FAILURE ANALYSIS FURTHER INVESTIGATED. THE SETUP FRU LOWER (SFL) TO AXES CONTROLLER TORNADO (ACT) CABLES (LOW VOLTAGE DIFFERENTIAL SIGNALING (LVDS) HARNESS AND THE ENCODER HARNESS) WERE ALSO REPLACED AS A FIX FOR THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE DISTAL SETUP JOINT (SUJ) WAS RETURNED FOR ERROR 26002. THE ERROR WAS REPLICATED IN-HOUSE AND VIA ERROR LOGS. THE DISTAL SETUP JOINT (SUJ) WENT THROUGH PSC FIXTURE TEST PLATFORM (PFTP) TESTING AND FAILED NODE CHECK. THE UNIVERSAL POWER DISTRIBUTOR (UPD) CFG UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED ERRORS 26002 AND 319 COULD NOT BE REPRODUCED, HOWEVER THE ERRORS WERE CONFIRMED AND VERIFIED VIA ERROR AND SYSTEM LOGS. THE UPD CFG UNIT WAS INSTALLED AND TESTED ON THE FINAL TEST SYSTEM 1, PROGRAMMED, AND SYSTEM STARTED AT NORMAL MODE WITH NO ERRORS OR FAILURE MESSAGE. VERIFIED ALL AXES WITH NO ERRORS AND FAILURE. POWER CYCLES WERE PERFORMED 10 TIMES, AND ALL PASSED. THE ASSEMBLY REMAIN ON THE SYSTEM FOR ONE HOUR IN NORMAL MODE, WITH NO FAILURES AND NO ERRORS. PERFORMED CHECK ON BATTERY POWER TEST AND HELM CONTROL TEST, AND ALL TESTS PASSED. ERROR 319 WAS POINTING TO A UNIVERSAL SURGICAL MANIPULATOR (USM4) DISTAL ISSUE AND NOT WITH THE UPD CFG ISSUE. THIS UPD CFG UNIT IS IN GOOD PHYSICAL CONDITION. THE UNIVERSAL MASTER CONTROLLER (UMC) CFG UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED ERRORS 26002 AND 319 COULD NOT BE REPRODUCED NOR CONFIRMED OR VERIFIED VIA ERROR AND SYSTEM LOGS. THE UNIT WAS REPLACED TO RESOLVE ERROR 26002. THIS UMC CFG UNIT WAS INSTALLED AND TESTED ON THE FINAL TEST SYSTEM 1, PROGRAMMED, AND SYSTEM STARTED AT NORMAL MODE WITH NO ERRORS AND FAILURE MESSAGE. VERIFIED ALL AXES WITH NO ERRORS AND FAILURE. POWER CYCLES WERE PERFORMED 12 TIMES, AND ALL PASSED. THE BOARD REMAIN ON THE SYSTEM FOR IDLING OVERNIGHT IN NORMAL MODE, WITH NO FAILURES/ERRORS TRIGGERED. DROVE THE PATIENT SIDE CART (PSC) BOOM, UNIVERSAL SURGICAL MANIPULATOR (USM) RANGE OF MOTION, CAMERA MOTION, HELM CONTROL TEST, WITH NO ERROR MESSAGE AND NO FAILURE. CHECKED VOLTAGE AND CURRENT, TEMP SENSORS AND ALL PASSED WITH NORMAL RANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY NON-TRANSTHORACIC SURGICAL PROCEDURE, A NON-RECOVERABLE FAULT 26002. TECHNICAL SUPPORT ENGINEER (TSE) ADVISED TO REBOOT THE SYSTEM AND AFTER DOING THE SYSTEM BOOTED UP WITH A RECOVERABLE FAULT 319 POINTING TO ARM 4 (NODE 194 -> TORNADO). TSE OFFERED TO DEACTIVATE THE FAULT CAUSING ARM AND TO PERFORM THE PROCEDURE WITH 3 ARMS OF THE SYSTEM, BUT SURGEON DECIDED TO CONVERT TO A LAPAROSCOPIC PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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
    494795 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

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