BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17813574 · Received September 25, 2023

    Report

    Report Number
    2955842-2023-18711
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    September 1, 2023
    Report Date
    September 1, 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
    SP
    Reporter Occupation
    NURSE
    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 CONFIGURED THE E-100 GENERATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY SURGICAL PROCEDURE, THERE WAS A FIRING ISSUE WITH THE E-100 GENERATOR. THE CUSTOMER COULD NOT USE THE VESSEL SEALER EXTEND (VSE) INSTRUMENT ON THE E-100 GENERATOR. THE CUSTOMER CONTACTED A CLINICAL SALES REPRESENTATIVE (CSR) WHEN THE ISSUE OCCURRED AND WAS ADVISED ON USING THE ERBE GENERATOR INSTEAD TO CONTINUE WITH THE PROCEDURE. THE CUSTOMER CONTACTED INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AFTER THE PROCEDURE WAS COMPLETED TO REPORT THE ISSUE. THE CUSTOMER STATED THAT THEY RESTARTED THE E-100 GENERATOR AND REPLACED THE VSE INSTRUMENT. THE CUSTOMER ALSO RECALLED THAT THE PORT LED INDICATOR AND POWER BUTTON ON THE E-100 GENERATOR WERE BOTH WHITE, INDICATING THE INSTRUMENT WAS PROPERLY CONNECTED TO THE E-100 GENERATOR AND THE UNIVERSAL SURGICAL MANIPULATOR (USM). ADDITIONALLY, THE CUSTOMER CHECKED AND CONFIRMED THAT THE SERIAL CABLE WAS PROPERLY CONNECTED FROM THE BACK SIDE OF THE E-100 GENERATOR TO THE CORE COMPONENT ON THE VISION SIDE CART (VSC). THE POWER CORD WAS ALSO CONNECTED TO THE VSC POWER STRIP. THE TSE INFORMED THE CUSTOMER THAT THE E-100 GENERATOR NEEDED TO BE CONNECTED TO A DEDICATED NOISE-FREE AC PLUG, WITHOUT ANY POWER STRIP. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241566 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

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