BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971335 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-13982
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    May 22, 2020
    Report Date
    May 22, 2020
    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
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM3) TO CORRECT THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PARTS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED AND REPRODUCED THE REPORTED FAILURE (ERRORS 23087 ON DOF 7). THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED ERROR 23087 ON (DEGREES OF FREEDOM) DOF 7. THE UNIT FAILED ON A PFTP AS IT FAILED THE CARRIAGE FRICTION SPEED LOW AND HIGH TESTS ON DOF 7. THE UNIT ALSO FAILED ON A PFTP AS IT FAILED THE CARRIAGE STRENGTH TEST ON DOF 7. THE CARRIAGE WAS OPENED UP AND ROTOR BEARING DEBRIS WAS FOUND ON THE DOF 7 WINDOW OF THE ISA. THE UNIT WENT THROUGH MORE TESTING ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) AND PASSED DIRECTION TESTS, LISSAJOUS, CVA CHARACTERIZATION, SINE CYCLE, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, AND CARRIAGE SWITCHES TEST. THE ISA BOARD, DOF 7 ROTOR, AND DOF 7 GEARBOX WILL BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HEMICOLECTOMY SURGICAL PROCEDURE, SYSTEM FAULTED DURING SURGERY WITH ERROR 23087 ON ARM 3. OR STAFF REMOVED INSTRUMENT AND POWER CYCLED SYSTEM BEFORE CALLING, FAULT 23087 RETURNED ON POWER UP. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED AND ASKED OR STAFF TO REMOVE INSTRUMENTS AND POWER CYCLE SYSTEM AND EMERGENCY POWER OFF (EPO) OF PATIENT SIDE CART (PSC). FAULT RETURNED ON POWER UP. TSE ASKED OR STAFF TO FOLLOW PROMPTS TO DISABLE ARM 3. TSE INFORMED OR STAFF THAT ARM 3 WILL NEED SERVICE. SURGEON CONTINUED WITH ROBOTIC SURGERY WITH ARM 1, ARM 2 AND ARM 4. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478310 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-42 N/A 00886874110720

    Patients

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