BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17137319 · Received June 15, 2023

    Report

    Report Number
    2955842-2023-16354
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 22, 2023
    Report Date
    May 22, 2023
    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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ISSUE WITH THE VESSEL SEALER (VS) INSTRUMENT AND A MESSAGE TO MATCH GRIP, 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. FSE CONFIRMED THE REPORTED FAILURE ON THE ERBE. THE ERBE WAS REPLACED. THE SYSTEM TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) WAS ANALYZED AND THE REPORTED ISSUE WITH THE VESSEL SEALER (VS) AND U-02 ERROR ON START-UP WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE UNIT WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR REPAIR. THE COMPLAINT REGARDING AN ISSUE WITH THE VS INSTRUMENT AND A MESSAGE TO MATCH GRIP WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SITE HAD AN ISSUE WITH THE VESSEL SEALER (VS) INSTRUMENT AND A MESSAGE TO MATCH GRIP. THE LOGS SHOWED NUMEROUS C-01 ERRORS FOR ERBE. THE SITE HAD CHANGED OUT THE INSTRUMENT WITH NO CHANGE. THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE SITE TO RESTART THE ERBE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057752 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-19 N/A 00886874110898

    Patients

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