BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17067610 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15836
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    September 10, 2020
    Report Date
    September 10, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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. FSE REPLACED THE REDUNDANT MEDICAL GRADE POWER SUPPLY (RMGPS) DUE TO PERSISTENT ERROR 417 AND LOSS OF POWER. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) ALSO RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) ERBE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPRODUCED THE CUSTOMER REPORTED COMPLAINT. THE UNIT WAS INSTALLED INTO THE TEST SYSTEM AND RAN IN NORMAL MODE. THE INDICATOR LED ON THE UNIT WAS NOT LIT INDICATING AN ISSUE WITH CORE B. THE UNIT WAS POWER CYCLED MULTIPLE TIMES AND IT TRIGGERED ERROR 417.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE DA VINCI-ASSISTED UNKNOWN GENERAL SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) SCREEN WAS BLACK, AND THE OPERATING ROOM (OR) STAFF NOTED A NON-RECOVERABLE ERROR. THE CUSTOMER RESTARTED THE SYSTEM WITH NO SUCCESS. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND NOTED ERRORS 23 AND 41014 POINTING TO AN ISSUE WITH SSC #1. THE CUSTOMER CONTINUED WITH THE PROCEDURE USING SSC #2. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE OR STAFF DID NOT COMPLETE TROUBLESHOOTING WITH THE TSE PRIOR TO CONVERTING TO A SECOND SURGEON SIDE CONSOLE (SSC). THE PROCEDURE WAS COMPLETED ROBOTICALLY USING THE SECOND SSC WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570207 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-10 N/A 00886874110744

    Patients

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