BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20092129 · Received August 28, 2024

    Report

    Report Number
    2955842-2024-18713
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 6, 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
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANNEX CODE C HAVE BEEN UPDATED BASED ON FAILURE ANALYSIS TESTING.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM WAS ANALYZED AND WAS CONFIRMED AS HAVING OCCURRED IN THE FIELD VIA LOGS AND WAS REPLICATED IN-HOUSE. LOGS SHOWS MULTIPLE 319 ERRORS (ACC NOT FOUND) ON ARM 4 POINTING TOWARDS THE ROLLING LOOP FIBER. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED A 319 ERROR. THE UNIT WAS ALSO TESTED ON A PFTP WHERE IT FAILED TESTS CHECK ALL BOARDS PRESENT (ACC NOT FOUND) AND FIBER TEST ON ROLLING LOOP. DURING INVESTIGATION, IT WAS NOTICED THAT THE ROLLING LOOP AND GROUND STRAPS WERE TANGLED IN THE SPAR. THE OLD ROLLING LOOP AND GROUND STRAPS WERE CUT OUT AND A GOLDEN ROLLING LOOP FIBER WAS INSTALLED, AND THE UNIT PASSED BOTH CHECK ALL BOARDS PRESENT AND FIBER TEST ON RETRY. THE UNIT PASSED ALL OTHER REQUIRED TESTS THAT HAS TO DO WITH THE REPORTED PROBLEM THEREAFTER. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY PROSTATECTOMY SURGICAL PROCEDURE, THE NURSE REPORTED TO AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) A NON-RECOVERABLE FAULT ON ARM 4. WHEN OR STAFF TRIED TO RECOVER THE FAULT, THE ARM HAD A NON-RECOVERABLE FAULT, AND THE ARM WAS DISABLED. THE SYSTEM LOGS CONFIRM ARM 4 ERRORS. THE TSE HAD THE CUSTOMER HARD CYCLE / EMERGENCY POWER OFF TO PATIENT SIDE CART (PSC) AND ARM 4 FAULTED WITH NON-RECOVERABLE ERROR 319 AT STARTUP. THE TSE WAS UNABLE TO CONFIRM 319 ERROR IN THE SYSTEM LOGS AT THE TIME OF THE CALL. THE CUSTOMER WAS FINISHED WITH THE ROBOTIC PORTION OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127872 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

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