BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16210668 · Received January 19, 2023

    Report

    Report Number
    2955842-2023-10159
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 14, 2022
    Report Date
    December 20, 2022
    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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ARM3 STOPPED WORKING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED ARM 3 TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND FOUND THAT THE REPORTED 26016/2202 ERROR ON CARRIAGE AXIS 1 (DOF 5) WAS CONFIRMED/REPLICATED. THE USM GENERATED A 26016 ERROR (DOF 5) DURING START-UP IN NORMAL MODE, DOF 5 CARRIAGE GEARBOX DID NOT ROTATE WHEN PRESSING BOTH SA PRESENCE PINS (FOR CARRIAGE GEARBOXES MOVEMENT) ON IN-HOUSE SYSTEM AND CAUSED INSTRUMENT ENGAGEMENT FAILURE/ISSUE. FAILED CARRIAGE FRICTION LOW AND CARRIAGE FRICTION HIGH SPEED AT PFTP WITH A 26016 ERROR ON DOF 5. DOF 5 ALSO FAILED CARRIAGE STRENGTH TEST (STIFFNESS) ON PFTP. FURTHER INVESTIGATION SHOWED DOF 5 CARRIAGE GEARBOX WAS PHYSICALLY STUCK (HARD TO TURN), DUE TO A SUNKEN GEARBOX BEARING CAUSING THE ENGAGEMENT ISSUE, FRICTION FAILURE AND CARRIAGE STRENGTH FAILURE. RUBBING MARKS ALSO WAS FOUND INSIDE OF ISA PCA'S DOF 5. DOF 5 GEARBOX AND ROTOR WILL BE REPLACED AS A FIX THE REPORTED PROBLEM. ALL PRESENCE PINS WILL BE REPLACED TO ACCOMMODATE THE CARRIAGE REPAIR. THE REMOVED CARRIAGE WILL BE REWORKED IN THE CARRIAGE REWORK CELL. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: FSE HAS REPLACED USM3 IN ACCORDANCE WITH ISI PROCEDURES TO RESOLVE REPORTED ISSUE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UMBILICAL HERNIA SURGICAL PROCEDURE, ARM3 STOPPED WORKING, IT DID NOT ENGAGE THE CAMERA. CUSTOMER TRIED ANOTHER CAMERA AND THE ISSUE PERSISTED. CUSTOMER MOVED THE CAMERA TO ARM2 AND THE CAMERA ENGAGED PROPERLY. SYSTEM LOGS SHOW MULTIPLE ENGAGEMENT ERRORS, INDICATING FAILURE TO ENGAGE A CAMERA. CUSTOMER CONTINUED THE PROCEDURE USING ARM2 AS THE CAMERA ARM. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE CUSTOMER WAS ABLE TO USE ALL 4 ARMS TO COMPLETE THE CASE AS THEY MOVED CAMERA TO ARM4 AND ATTACHED ANOTHER INSTRUMENT TO ARM3. THERE WAS LESS THAN A 15 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105524 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A 00886874110720

    Patients

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