BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18991971 · Received March 28, 2024

    Report

    Report Number
    2955842-2024-12928
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 5, 2024
    Report Date
    March 5, 2024
    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
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE, WHERE IT TRIGGERED AN ERROR 319. THE UNIT WAS ALSO TESTED ON THE IN-HOUSE SYSTEM, WHERE IT FAILED TO CHECK ALL BOARDS TEST. FAILURE INDICATED A POWER ISSUE WITH THE BOARD. AFTER INSTALLING THE GOLDEN BOARD, THE UNIT PASSED THE CHECK OF ALL BOARDS AND THE FIBER READING TEST. FA REPLICATED ERROR 319 WITH THE ORIGINAL COMPONENT REINSTALLED.

    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. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE USM FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF 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 PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE SYSTEM HAD NON-RECOVERABLE FAULT ON UNIVERSAL SURGICAL MANIPULATOR (USM1). AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE ERROR LOGS AND FOUND ERROR 319 POINTING TO USM 1 AXES CONTROLLER CARRIAGE (ACC) NODE. THE TSE GUIDED THE CUSTOMER TO POWER THE SYSTEM OFF, PERFORMING AN EMERGENCY POWER OFF (EPO) ON PATIENT SIDE CART (PSC) AND MOVING THE USM 1 CARRIAGE MANUALLY. AFTER DOING SO, THE ERROR REOCCURRED. THE TSE GUIDED THE CUSTOMER TO DISABLE USM 1 IN ORDER TO CONTINUE WITH PROCEDURE WITH 3 USMS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910140 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

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