BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 19785630 · Received July 19, 2024

    Report

    Report Number
    2955842-2024-17140
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 25, 2024
    Report Date
    June 25, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 EVENT. THE FSE REPLACED THE COMMON COMPUTER CONTROLLER (CCC) BOARD ON THE VISION CART TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE CCC BOARD INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE BOARD WAS INSTALLED ON AN IN-HOUSE EFT SYSTEM, PROGRAMMED TO SOFTWARE (WJ79), AND POWERED ON NORMALLY WITH NO ERROR CODES PRESENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER AND CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED TECH SUPPORT STATING THE SYSTEM FAULTED. THE SYSTEM HAD NO CONNECTION ISSUES LIKE THE HUB CONNECTED TO THE WRONG INPUT. THE CUSTOMER PERFORMED SEVERAL HARD POWER CYCLES AND THE ISSUE PERSISTED. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS WHICH SHOWED 311 ERROR POINTING BETWEEN THE COMMON COMPUTER CONTROLLER (CCC) AND MACHINE LEARNING (MLX) BOARD. THE PROCEDURE WAS CONVERTED TO ANOTHER SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033524 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES