BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21316010 · Received February 5, 2025

    Report

    Report Number
    2955842-2025-01152
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 10, 2025
    Report Date
    January 10, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND THE REPORTED FAILURE (ERBE NO POWER) WAS CONFIRMED AND REPRODUCED ON ERBE CONNECTED TO SYSTEM. LOGS (1100 ERROR) CONFIRMING THE POWER FAULT OCCURRED IN THE FIELD. VISUAL INSPECTION:(SCRATCHES ON FRONT GREY PANEL AND SMALL NICK ON BOTTOM OF GREY PANEL ACROSS THE EDGE.) ERBE UNIT FUSES WAS REPLACED WITH NEW 8A FUSES. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE BASED ON ELECTRICAL AND FIBEROPTIC DEFECTS. LOSS OF AC POWER TO THE CORE FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, INTEGRATED ELECTRO SURGICAL UNIT HAD NO POWER. THE CUSTOMER STATED THAT THEY TRIED POWER CYCLING, HARD CYCLING, NEW POWER CORD, AND MOVING OUTLETS BUT IESU WOULD NOT POWER ON. THE SITE DID NOT HAVE A SECONDARY VISION SIDE CART (VSC) OR THIRD-PARTY ELECTRO SURGICAL GENERATOR UNIT (ESU). THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857980 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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