BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16230322 · Received January 23, 2023

    Report

    Report Number
    2955842-2023-10254
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    December 27, 2022
    Report Date
    December 27, 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
    NE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A RECOVERABLE FAULT 23062 ON ARM 3, AN INVESTIGATION IS IN PROGRESS 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 WENT ON SITE AND REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A UNIVERSAL SURGICAL MANIPULATOR (USM), WAS REPLACED AFTER THE COMPLETION OF THE PROCEDURE DUE TO REPEATED RECOVERABLE FAULTS. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE USM WAS ANALYZED AND THE ERROR 23062 WAS CONFIRMED BUT NOT REPLICATED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE BACK DRIVE TEST DUE TO NOISY PITCH. THE UNIT WAS ALSO TESTED ON THE TESTING PLATFORM WHERE THE DIRECTION TEST, SINE CYCLE, FRICTION, SENSOR CHECK, AND ALL BRAKE TESTS PASSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT RECOVERABLE FAULT 23062 WAS REPEATEDLY OCCURRING ON ARM 3. THE SYSTEM EVENT LOGS CONFIRM REPEATED OCCURRENCES OF ERROR 23062 REPORTED BY UNIVERSAL SURGICAL MANIPULATOR (USM) 3 AXIS 2, INDICATING A FAULTY MOTOR, ENCODER, AMPLIFIER OR CONNECTION ON USM 3. THE TSE ADVISED THE CUSTOMER THAT THE SURGEON COULD CHOSE TO DISABLE ARM 3 AND PROCEED USING THE REMAINING ARMS, IF THE ERROR IMPEDED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THIS EVENT OCCURRED DURING A LEFT HEMICOLECTOMY PROCEDURE ON (B)(6)2022. THE CUSTOMER CLARIFIED THAT THEY WERE ABLE TO RECOVER FROM THE FAULT WHENEVER IT OCCURRED DURING THE PROCEDURE, AND THEY DIDN'T DISABLE ARM 3 DUE TO THE ISSUE. THERE WAS NO SIGNIFICANT DELAY TO THE PROCEDURE AS THEY WOULD JUST PRESS THE BUTTON TO RECOVER WHEN THE FAULT OCCURRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED WITH NO PATIENT 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
    485341 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

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