BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18232183 · Received November 29, 2023

    Report

    Report Number
    2955842-2023-20654
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 2, 2023
    Report Date
    November 2, 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
    FL, US
    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. THE FSE WAS ABLE TO REPRODUCE THE REPORTED PROBLEM. THE FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) 3 TO RESOLVE THE INTERMITTENT 32097 ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT AND PERFORMED A FAILURE ANALYSIS. THE USM WAS ANALYZED AND FOUND TO HAVE NO FAILURE DURING IN-HOUSE TESTING. ERRORS 32097, 1126, AND 307 WERE CONFIRMED IN THE LOG BUT NOT REPLICATED DURING TESTING. THE ERRORS WERE POINTING TO THE AXES CONTROLLER, MOTOR (ACM), AND AXES CONTROLLER SPAR (ACS). THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND TRIGGERED NO ERRORS. THE UNIT WAS ALSO TESTED ON THE PSC (PATIENT SIDE CART) FIXTURE TEST PLATFORM (PFTP) AND PASSED ALL TESTS THAT WERE PERFORMED. UPON FURTHER INVESTIGATION, THERE WAS NO FLUID INTRUSION OR PHYSICAL DAMAGE. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLIDING HIATAL HERNIA SURGICAL PROCEDURE, UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WAS DISABLED DUE TO A RECOVERABLE FAULT THAT COULD NOT BE RESOLVED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LOGS AND FOUND NO ERRORS ON USM 3, BUT THE USER HAD PERFORMED A POWER CYCLE, AND THE LOGS MIGHT NOT BE LOADED AT THAT TIME. AFTER USM 3 WAS DISABLED, THE USER POWER CYCLED THE SYSTEM, AND A NON-RECOVERABLE FAULT OCCURRED. THE TSE FOUND ERROR 31030 POINTING TO THE VIDEO PROCESSOR (VP). THE TSE HAD THE CUSTOMER HARD POWER CYCLE THE VISION SIDE CART (VSC) AND CHECK THE VP CABLE CONNECTION AND POWER STATUS. THE SYSTEM POWERED BACK ON WITH NO FURTHER ISSUE, AND THE SITE CONTINUED WITH THE PROCEDURE WAS PLANNED. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044487 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

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