BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22180216 · Received June 10, 2025

    Report

    Report Number
    2955842-2025-24460
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    June 2, 2025
    Report Date
    June 2, 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
    CH
    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 WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE UNIT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED, AND THE REPORTED PROBLEM WAS ABLE TO BE CONFIRMED USING REMOTEFE 25913. UNIT WAS TESTED USING SYSTEM ON STARTUP UNIT DISPLAYED C-34 VOLTAGE WHICH THEN TURNED INTO C-00 IN ERROR LOG. UPON VISUAL INSPECTI THERE WERE NO ISSUES FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED GYNECOLOGY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED ERBE HAD ERROR C-34 WHEN THEY ATTEMPTED TO ACTIVATE MONOPOLAR INSTRUMENT. THE CUSTOMER ATTEMPTED TO SWAP INSTRUMENT, ENERGY ACTIVATION CABLE, POWER CYCLE THE ERBE, BUT THE ISSUE PERSISTED. THE CUSTOMER USED A 3RD PARTY ELECTROSURGICAL GENERATOR UNIT (ESU) TO COMPLETE THE PROCEDURE AND THE SURGERY WAS COMPLETED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A DA VINCI-ASSISTED RADICAL SURGERY FOR CERVICAL CANCER WAS PERFORMED ON (B)(6) 2025, STARTING AT 19:30. PORTS WERE SUCCESSFULLY PLACED BEFORE ANY ISSUES WERE IDENTIFIED. THE SYSTEM'S FUNCTIONALITY WAS CHECKED UPON POWERING ON, BUT IT INITIALLY POWERED ON WITH ERRORS. THE ISSUE WAS RESOLVED AFTER REPLACING THE ERBE WITH A THIRD-PARTY ESU.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806847 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-64 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES