BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17067650 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15852
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    September 17, 2020
    Report Date
    September 17, 2020
    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
    NY, 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 COMPLAINT. THE FSE CONFIRMED MASTER TOOL MANIPULATOR (MTM2) ERROR 23008 AND REPLACED THE LEFT MTM ACCORDINGLY. THE MTM WAS REPLACED TO CORRECT REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) ALSO RECEIVED THE MASTER TOOL MANIPULATOR (MTM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPRODUCED THE CUSTOMER REPORTED COMPLAINT. DURING FAILURE ANALYSIS, ERROR 23008 ALONG AXIS 8 / GIMBAL GRIP) WAS REPRODUCED DURING CALIBRATION (VIA MATLAB). THE FOLLOWING PARTS WILL BE REPLACED AS A FIX: EMBEDDED SERIALIZER FOR MASTER HANDLE (ESMH), PRINTED CIRCUIT ASSEMBLY (PCA), AXIS 7 MOTOR, AXIS 7 PINION GEAR, AXIS 7 BEVEL GEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY PROCEDURE, ERRORS PRESENTED WHEN THE SURGEON WAS TIGHTLY TYING A KNOT. THE CUSTOMER CONTACTED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THE ISSUE THAT OCCURRED EARLIER IN THE CASE. PRIOR TO THE SUPPORT CALL, THE CUSTOMER POWER CYCLED THE SYSTEM WITH NO CHANGE. THE SURGEON MOVED FROM ONE SURGEON SIDE CONSOLE (SSC) TO THE OTHER SSC 2 AND THE ISSUE WAS RESOLVED. ONSITE WAS NOT CONNECTED AT TIME OF THE CALL. THE TSE REQUESTED THAT THE CUSTOMER EMAIL ERROR LOGS. THE TSE REVIEWED THE LOGS AND IDENTIFIED THAT ERROR 23008 WAS OCCURRING ON MASTER TOOL MANIPULATOR (MTM). CUSTOMER ASKED IF THEY COULD KEEP USING BOTH SSC DURING THE CASE AND THE TSE ADVISED THE CUSTOMER THAT THE CHOICE IS UP TO THE SURGEON; THE ERROR WAS LIKELY TO CONTINUE IF MTML2 IS USED UNTIL THE SYSTEM IS SERVICED. CUSTOMER OPTED TO CONTINUE WITH THE CASE. THE PROCEDURE CONTINUED TO BE COMPLETED AS PLANNED WITH A DUAL CONSOLE SET UP WITH SSC2 BEING PRIMARY. THERE WAS NO REPORTED INJURY. ON 17-SEP-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CUSTOMER HAS SPOKEN WITH THE FIELD SERVICE ENGINEER (FSE) TO ARRANGE FOR THE SYSTEM TO BE LOOKED AT TOMORROW. THE PROCEDURE WAS IN OPERATING ROOM (OR) A9 WITH THE LISTED CONSOLE SURGEON. IT WAS REPORTED THAT THE PROCEDURE COMPLETED ROBOTICALLY AS A DUAL CONSOLE SET UP. THERE WAS NO REPORT OF INJURY. THERE WAS NO REPORT OF ANY SUTURING ISSUES, ADDITIONAL BLEEDING, OR COMPLICATIONS. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745864 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-09 N/A 00886874110744

    Patients

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