BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17067394 · Received June 5, 2023

    Report

    Report Number
    2955842-2023-15748
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    October 18, 2021
    Report Date
    October 19, 2021
    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
    PA, 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. THE FSE BOOTED THE SYSTEM UP AND AN ERROR 90 OCCURRED. THE SYSTEM LOGS CONFIRMED ERROR 90. THE FSE DISCONNECTED THE SURGEON SIDE CONSOLE (SSC) AND RESTARTED THE SYSTEM WITH NO ERROR 90 IN THE SYSTEM LOG. THE FSE REPLACED PERSONALITY MODULE SURGEON CONSOLE (PMSC), ON THE SSC, AND PROGRAMED THE SYSTEM WITH THE NEW PMSC. THE SYSTEM WAS RESTARTED SEVERAL TIMES AND ERROR 90 DID NOT REOCCURRED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PMSC INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT, "ERROR 90 ON PMSC." FA FOUND AN OUT-OF-RANGE VOLTAGE VALUE FROM THE BOARD'S ANALOG TO DIGITAL CONVERTER (ADC) REGISTER. THE PMSC WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE SYSTEM START-UP FAILED WITH AN ERROR 90, AND THE THE 1.8V ADC BOARD VOLTAGE READING FAILED OUT OF RANGE. THE VIDEO BRANCH (VBR) HAS FAILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COLOSTOMY CLOSURE SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE FAULT. THE OPERATING ROOM (OR) STAFF WAS NOT ABLE TO RECOVER FAULT AND WAS NOT ABLE TO CONTACT INTUITIVE SURGICAL, INC. (ISI)'S TECHNICAL SUPPORT. THE SURGEON CONVERTED THE PROCEDURE TO A LAPAROSCOPIC SURGERY. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE SYSTEM LOGS AND FOUND ERROR 90, POINTING TO A PERSONALITY MODULE SURGEON CONSOLE (PMSC) ISSUE. THE TSE ASKED THE OPERATING ROOM STAFF TO CYCLE THE SYSTEM POWER AND CYCLE THE VISION SIDE CART (VSC), PATIENT SIDE CART (PSC), AND SURGEON SIDE CONSOLE (SSC) CIRCUIT BREAKERS. THE TSE THEN ASKED THE OPERATING ROOM STAFF TO RESEAT ALL THE BLUE FIBER CABLES AND VERIFY THERE WERE NO DIGITAL VIDEO INTERFACE (DVI) CABLES CONNECTED AT THE BACK OF THE SSC. HOWEVER, ERROR 90 RETURNED UPON POWERING UP. THE PROCEDURE WAS COMPLETED VIA LAPAROSCOPIC SURGERY AND THERE WAS NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745851 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-23 N/A 00886874110744

    Patients

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