BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15741011 · Received November 5, 2022

    Report

    Report Number
    2955842-2022-15097
    Event Type
    Malfunction
    Date Received
    November 5, 2022
    Date of Event
    October 5, 2022
    Report Date
    October 6, 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
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE (ERROR 319) WAS CONFIRMED AND REPLICATED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED 319 ERRORS. THE UNIT FAILED THE FIBER TEST ON THE ACA BOARD. THE ACA BOARD WAS SWAPPED OUT WITH A NEW ONE AND THE ERRORS NO LONGER OCCURRED. THE ORIGINAL AC BOARD WAS REINSTALLED, AND THE ERRORS RETURNED. THE UNIT WAS TESTED ON PSC FIXTURE TEST PLATFORM (PFTP) WITH A NEW ACA BOARD AND PASSED DIRECTION TEST, LISSAJOUS, CHIPENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION, SENSORS CHECK, SINE CYCLE, FRICTION TEST, CARRIAGE FRICTION TEST, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST CARRIAGE STRENGTH TEST, AND CARRIAGE SWITCHES TEST. THE ACA BOARD WILL BE REPLACED AS A FIX TO THE REPORTED PROBLEM FROM THE FIELD.

    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. THERE WAS A 319 ERROR ON ARM 3 ON TORNADO BOARD DOWN THROUGH UNIVERSAL SURGICAL MANIPULATOR (USM). THE DISTAL SET UP JOINT (SUJ) WAS REPLACED, BUT THE USM STILL HAD THE 319 ERROR. THE FSE ALSO REPLACED THE USM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE SUJ INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REPRODUCED THE REPORTED COMPLAINT. UNIT WAS INSTALLED ON SYSTEM AND TRIGGERED REPORT ERROR 319. UNIT WAS MOVED TO PSC FIXTURE TEST PLATFORM (PFTP) FOR FURTHER TESTING WHERE IT FAILED INITIALIZE BRAKE TESTS. A GOLDEN SETUP FIELD REPLACEABLE UNIT LOWER (SFL) WAS SWAPPED, AND UNIT FAILED REPEATEDLY AT SAME PLACE. THE ORIGINAL SFL WAS INSTALLED BACK ON. THE AXES CONTROLLER TORNADO (ACT) BOARD WAS SWAPPED WITH A GOLDEN PART AND PASSED ALL TESTS. ORIGINAL ACT WAS PUT BACK IN AND RETESTED, CONFIRMING THE FAILURE AGAIN. A COMPONENT FAILUR EON THE SUJ WAS CONFIRMED. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT, BUT DEVICE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. VERIFICATION OF THE EVENT DETAILS WAS PERFORMED BY AN ISI TSE. PER REVIEW, THE FOLLOWING WAS CONFIRMED: AN INGUINAL HERNIA - BILATERAL WAS PERFORMED ON SYSTEM (B)(4) ON (B)(6) 2022. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A UNIVERSAL SURGICAL MANIPULATOR (USM) WAS REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY USING 3 ARMS. 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 CONVERSION/ABORTION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA GENERAL SURGICAL PROCEDURE, THERE WAS A RECOVERABLE FAULT ON ARM 3. TECHNICAL SERVICE ENGINEER (TSE) WAS UNABLE TO VIEW LOGS AS THE SYSTEM WAS NOT CONNECTED TO ONSITE, SO THE STAFF SHARED A PICTURE OF THE LOGS. ERROR 319 POINTED TOWARDS ARM 3. THE OPERATING STAFF STATED THEY POWER CYCLED THE SYSTEM MULTIPLE TIMES TO TRY CLEAR THE MESSAGE WITH NO SUCCESS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227378 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A 00886874110720

    Patients

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