BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19256431 · Received May 6, 2024

    Report

    Report Number
    2955842-2024-14059
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 12, 2024
    Report Date
    April 12, 2024
    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
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR WAS RETURNED FOR FAILURE ANALYSIS. THE GENERATOR ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THE ERROR LOGS LISTED MULTIPLE ERRORS M-12, M-0B, M-1F, M-B0, C-84, C-00, M-31.

    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. FSE IDENTIFIED ERBE GENERATOR FAILED THE ELECTRICAL SAFETY TEST (EST) DURING PREVENTATIVE MAINTENANCE (PM). FSE REPLACED THE ERBE TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. ISI RECEIVED THE ERBE GENERATOR FOR THE FAILURE ANALYSIS; HOWEVER, THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHROURETERECTOMY SURGICAL PROCEDURE, CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED "ACTIVATION HAS BEEN INTERRUPTED" MESSAGE APPEARED DURING ENERGY ACTIVATION. PRIOR TO CONTACTING TSE, CUSTOMER ATTEMPTED TO TROUBLESHOOT THE ISSUE BY USING BACKUP MONOPOLAR INSTRUMENT CORD, ANOTHER MONOPOLAR INSTRUMENT AND POWER CYCLED ERBE GENERATOR, BUT ISSUE PERSISTED. TSE REVIEWED LOGS AND FOUND ERROR C-34 POINTING TO ERBE GENERATOR. TSE INFORMED CUSTOMER THAT ERBE GENERATOR NEEDED SERVICE. TSE ASKED CUSTOMER TO LOOK FOR BACKUP COVIDIEN GENERATOR AND ENERGY ACTIVATION CABLE. ISI CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED TSE AND INQUIRED IF CUSTOMER WAS ABLE TO USE THE FORCE TRIAD GENERATOR IN PLACE OF THE ERBE. TSE INFORMED CSR THAT THE CUSTOMER WOULD NEED A CABLE TO CONNECT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401666 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-33 N/A 00886874110898

    Patients

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