BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971344 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-13991
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    June 11, 2020
    Report Date
    June 11, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    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. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THAT THE USM HAD FAILED NORMAL MODE AS IT TRIGGERED 23094 AND 32101 ERRORS. THE ACA BOARD WAS SWAPPED WITH A NEW ONE AND THE ERRORS NO LONGER OCCURRED. THE ORIGINAL ACA BOARD WAS REINSTALLED AND THE ERRORS RETURNED. THE UNIT WENT THROUGH MORE TESTING ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) AND PASSED DIRECTION TESTS, LISSAJOUS, CVA CHARACTERIZATION, SINE CYCLE, FRICTION TEST, CARRIAGE FRICTION TEST, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, CARRIAGE STRENGTH TEST, AND CARRIAGE SWITCH TEST. THE ACA PCA WILL BE REPLACED AS A FIX. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SYSTEM GENERATED REPEATED RECOVERABLE FAULTS THAT WOULD NOT RECOVER. THE OR STAFF DISABLED ARM 4 PRIOR TO CALLING TECHNICAL SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED LOGS AND OBSERVED ERRORS 23000, 23094 AND 32101 ON ARM 4. THE SURGEON MOVED ARM 4 AWAY AND CONTINUED WITH CASE USING ARM 1, ARM 2 AND ARM 3. THE TSE ADVISED THE OR STAFF TO CYCLE SYSTEM POWER AT END OF PROCEDURE. TECHNICAL SUPPORT ALSO PROVIDED INSTRUCTIONS ON HOW TO STOW THE DAMAGED ARM 4. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478319 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