BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971415 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-14037
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    November 25, 2020
    Report Date
    November 25, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THE FSE REPLACED THE SYSTEM'S UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE, AS IT TRIGGERED ERROR 319. WHEN THE ROLLING LOOP FIBER SWAPPED WITH A NEW ONE, THE ERROR NO LONGER OCCURRED. AFTER THE ORIGINAL ROLLING LOOP FIBER CABLE WAS REINSTALLED, THE ERROR 319 CAME BACK. THE SYSTEM ALSO LOGGED ERROR 319 AND 31226. WHEN THE USM WAS TESTED ON IN-HOUSE SYSTEM (USING NEW ROLLING LOOP, FIBER CABLE) IT PASSED THE DIRECTION TESTS, LISSAJOUS, CHIPENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION, SINE CYCLE, CARRIAGE FRICTION TESTS, BRAKE RELEASE TEST, BRAKE HOLD TEST, CARRIAGE SENSORS CHECK, AND THE ADVANCED BRAKE TEST. THE ROLLING LOOP FIBER ASSEMBLY WAS 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 ERROR 319, POINTING TO THE SYSTEM'S UNIVERSAL SURGICAL MANIPULATOR (USM) 4. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS UNABLE TO VIEW SYSTEM EVENT LOGS DUE TO THE REMOTE ONSITE NOT BEING ACTIVATED. THE TSE ADVISED THE CUSTOMER TO POWER-CYCLE THE SYSTEM, USING THE EMERGENCY POWER OFF (EPO) BUTTON, AND WAIT A MINIMUM OF ONE MINUTE UNTIL RESTART. THE CUSTOMER ELECTED TO PERFORM THE PROCEDURE WITH ONLY THREE USMS, BY DISABLING THE USM 4. THE CUSTOMER PLANNED ON TROUBLESHOOTING THE SYSTEM AFTER COMPLETING THE SURGERY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741633 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-22 N/A

    Patients

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