BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19029716 · Received April 2, 2024

    Report

    Report Number
    2955842-2024-13026
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Report Date
    March 20, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    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. FSE REPLACED THE DISTAL SET UP JOINT (SUJ) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THE SET UP JOINT (SUJ) WAS RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM ON 04/24/2024. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS DUE TO ERROR 23013 AND 2310. THE ERROR WAS CONFIRMED IN THE FIELD VIA LOGS, AND THE ERRORS WERE REPLICATED IN HOUSE. THE UNIT FAILED WRIST BRAKE TEST AND HAD A DAMAGED SFL CIRCUIT BOARD. FOLLOW-UP WITH THE CUSTOMER CONFIRMED THE SYSTEM WAS ABLE TO START UP WITHOUT ERRORS. THE CUSTOMER EXPERIENCED THE ERRORS APPROXIMATELY 1 HOUR AFTER THE START OF THE PROCEDURE. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO ANOTHER SYSTEM IN A DIFFERENT OPERATING ROOM AND CONFIRMED THE PROCEDURE COMPLETED WITH 4 ARMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE SYSTEM FAULTED WITH ERRORS: 23103 AND 23105. THE CUSTOMER RESTARTED THE SYSTEM WITHOUT ANY CHANGE. THEN, THE STAFF DISABLED THE UNIVERSAL SURGICAL MANIPULATOR 4 (USM) TO FINISH SURGERY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689198 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-22 N/A

    Patients

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