BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17028239 · Received May 30, 2023

    Report

    Report Number
    2955842-2023-15197
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    October 20, 2021
    Report Date
    October 20, 2021
    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
    NURSE
    Health Professional
    Yes

    Narratives

    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. BASED ON THE FIELD SERVICE EVALUATION, THE FSE WAS UNABLE TO REPLICATE THE ISSUE. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) AS A PRECAUTION. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPLICATE THE CUSTOMER REPORTED COMPLAINT (ENGAGEMENT & SCOPE ISSUES WITH 22020 ERRORS). HOWEVER, THE ERROR LOGS/SYSTEM LOGS SHOWED THAT THERE WERE VARIOUS 22020 AND 25930 ERRORS ON DOF'S 5, 6, & 8. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM WITH DIFFERENT SCOPES, DRAPES, MULTIPLE STERILE ADAPTERS, AND THE INSTRUMENTS WITH NO ENGAGEMENT ISSUES. THE UNIT PASSED NORMAL MODE. THE UNIT WENT THROUGH MORE TESTING ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) AND PASSED DIRECTION TESTS, LISSAJOUS, SENSORS CHECK, SINE CYCLE, CARRIAGE FRICTION TEST, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, CARRIAGE STRENGTH TEST, AND CARRIAGE SWITCHES TEST. THE TOP PLATE WILL BE REPLACED, AND THE CARRIAGE WILL BE UPGRADED TO A -19 AS A PRECAUTION TO THE REPORTED PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY-RADICAL W/LYMPHADENECTOMY SURGICAL PROCEDURE, THE 0-DEGREE ENDOSCOPE WOULD NOT ENGAGE ON ARM 3. THE SAME ENDOSCOPE WOULD ENGAGE ON ARM 2 WITHOUT ISSUES. THE CUSTOMER RE-DRAPED ARM 3 WITH NO SUCCESS. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO A LAPAROSCOPIC SURGERY WITHOUT ANY TROUBLESHOOTING. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS CONFIRMED ENGAGEMENT ERRORS 22020 ON THE UNIVERSAL SURGICAL MANIPULATOR #3 (USM3). THE TSE RECOMMENDED CHECKING FOR ANY PHYSICAL DAMAGE ON THE BLACK PRESENCE PINS ON ARM 3. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND CONFIRMED THAT THE LAPAROSCOPIC SURGERY WAS COMPLETED SUCCESSFULLY WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130808 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

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