BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20023325 · Received August 21, 2024

    Report

    Report Number
    2955842-2024-18173
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 23, 2024
    Report Date
    July 23, 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
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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. FSE REPLACED DISTAL AND PROXIMAL SET-UP JOINT (SUJ) AND UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS NOT RECEIVED THE DEVICES FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCTS ARE RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE UNIT WAS RETURNED FOR ERROR 23210. THE ERROR WAS CONFIRMED AND REPLICATED BECAUSE OF FLUID INTRUSION. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT WAS DISABLED WITH ERROR 23210 SHOWING ON THE SCREEN OF THE PATIENT SIDE CART. THE UNIT WAS ALSO TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED THE DIRECTION TEST. FLUID INTRUSION WAS FOUND ON THE AXES CONTROLLER SPAR HALL SENSOR (ACSH) AND A GOLD ACSH WAS INSTALLED TO PASS THE TEST.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE DISTAL SET-UP JOINT (SUJ) INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS DUE TO ERROR 23210. THE ERROR WAS CONFIRMED AS HAVING OCCURRED IN THE FIELD AND REPLICATED IN-HOUSE. ALSO, THE UNIT WAS TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) AND THE LOWER SETUP FIELD REPLACEABLE UNIT EXHIBITED PHYSICAL DAMAGED. ADDITIONALLY, THE PROXIMAL SUJ WAS RETURNED FOR FAILURE ANALYSIS DUE TO ERROR 23210. THE ERROR WAS CONFIRMED AS HAVING OCCURRED IN THE FIELD BUT NOT REPLICATED IN-HOUSE. UNIT WAS TESTED ON A PFTP, AND ALL TESTS PASSED. THE UNIVERSAL SURGICAL MANIPULATOR (USM) HAS ALSO BEEN RETURNED, BUT FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, AN ISSUE WITH THE UNIVERSAL SURGICAL MANIPULATOR 4 (USM4). THE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE SYSTEM EVENT LOGS AND NOTICED AN ERROR 23210 POINTING USM4. TSE ASKED TO PERFORM A HARD POWER CYCLE, EMERGENCY POWER OFF (EPO) AND MOVE USM4 TO ANOTHER POSITION AND TO RECOVER THE FAULT. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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
    2286543 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A 00886874110720

    Patients

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