BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971874 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14342
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    July 26, 2021
    Report Date
    July 26, 2021
    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
    003

    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 COMPLAINT. FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE 319 ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED A 319 ERROR. SYSTEM LOG AND REMOTE FE REIVEW REVEEALED ERRORS 319 AND 32058. THE FIBER PARALLELOGRAM SWAPPED WITH A NEW ONE AND THE ERRORS NO LONGER OCCURRED. WHEN THE ORIGINAL PARALLELOGRAM FIBER WAS REINSTALLED, THE ERROR RETURNED. THE UNIT WAS ALSO TESTED ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM WITH A NEW FIBER PARALLELOGRAM AND IT PASSED ALL REQUIRED TESTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WERE 319 ERRORS ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED SYSTEM LOGS AND CONFIRMED 319 ERRORS POINTING TO THE AXES CONTROLLER SPAR (ACS) AND AXES CONTROLLER CARRIAGE (ACC) BOARDS IN USM 1. THE SITE CUSTOMER DISABLED USM 1 AND CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781620 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

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