BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21260817 · Received January 28, 2025

    Report

    Report Number
    2955842-2025-00937
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 3, 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
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. 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 INTEGRATED ELECTROSURGICAL 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 ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS ON SYSTEM. THE M-11, M-18, AND C-06 ERRORS WERE IN THE LOGS. THE ROOT CAUSE IS ATTRIBUTED TO A DEFECTIVE COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURE THAT THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FAULTED WHILE TRYING TO USE MONOPOLAR ENERGY. THE SYSTEM LOGS CONFIRMED THAT IESU ERRORS C-06, M-18, AND M-11 OCCURRED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INQUIRED IF ANY ENVIRONMENTAL SOURCES OF ELECTROMAGNETIC INTERFERENCE WERE IN CLOSE PROXIMITY TO THE IESU; THE CUSTOMER CONFIRMED THERE WAS NONE. THE TSE RECOMMENDED DISCONNECTING THE IESU FOOTSWITCH PEDALS, BUT THE CUSTOMER DECLINED AS THE PROCEDURE WAS ONGOING. THERE WERE NO REPORTS OF PATIENT INJURY. PROCEDURE WAS COMPLETED. ISI PERFORMED FOLLOW-UP AND OBTAINED PATIENT RELATED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995863 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-21 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES.