BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17704234 · Received September 7, 2023

    Report

    Report Number
    2955842-2023-18295
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 16, 2023
    Report Date
    August 16, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE APPLIED CONTACT SPRAY ON J11 AND J12 CONNECTOR ON THE ACU SET UP JOINT (SUJ) DISTAL 4, ALSO ON CONTACT BETWEEN TORNADO, SUJ AND USM. THE ERROR DID NOT RETURN AFTER A FEW REBOOTS OF THE SYSTEM. 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 SURGICAL PROCEDURE, THE SYSTEM HAD AN ERROR ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE USM WAS DISABLED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER REVIEWED THE ERROR LOGS AND NOTED ERRORS 30/32097 POINTING TO A COMMUNICATION ISSUE BETWEEN AXES CONTROLLER SETUP (ACU) AND AXES CONTROLLER TORNADO (ACT). THE TSE ASKED THE CUSTOMER TO POWER CYCLE THE SYSTEM TO RECOVER THE USE OF THE SYSTEM. THE SURGEON WOULD FINISH THE SURGERY WITH 3 USMS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 3 USMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038386 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 N/A 00886874110720

    Patients

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