BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16595771 · Received March 22, 2023

    Report

    Report Number
    2955842-2023-11483
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    February 18, 2023
    Report Date
    February 20, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) LOST POWER, 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 NOTICED THAT THERE WAS AN "ENERGY DEVICE CONFLICT" MESSAGE ON THE CONSOLE SCREEN. THE FSE NOTICED THAT A CABLE WAS CONNECTED TO ONE OF THE ORIIO ENERGY PORTS. THE PORT HAD A RED LIGHT LIT. THE FSE REMOVED THE CABLE AND THE ERROR MESSAGE DISAPPEARED. THE IESU BEGAN TO RESPOND WHEN THE CONSOLE FOOT PEDALS WERE PRESSED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT REGARDING THE IESU NOT FUNCTIONING WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF THE IESU NOT FUNCTIONING IS ATTRIBUTED TO IMPROPER CUSTOMER SETUP. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) EXHIBITED A PERSISTENT ISSUE DURING THE PROCEDURE. SERVICE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) TO RESOLVE THE ISSUE AFTER THE COMPLETION OF THE PROCEDURE. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) LOST POWER. THE PROCEDURE WAS REPORTEDLY COMPLETED AS PLANNED WITH NO REPORTS OF PATIENT INJURY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS UNABLE TO PROVIDE ANY FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14021 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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