BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18458855 · Received January 5, 2024

    Report

    Report Number
    2955842-2023-21969
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    December 12, 2023
    Report Date
    December 12, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY DUE TO AN ISSUE WITH A NON-RECOVERABLE FAULT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM), BUT THE ISSUE REMAINED. THE FSE SWAPPED USM 2 AND USM 4 AND ONLY USM 2 POWERED UP. THE FSE REPLACED THE CARD CAGE TO RESOLVE THE ISSUE. THE NEW CARD CAGE WAS PROGRAMMED AND TESTED. THE SYSTEM WAS TESTED AND WAS READY FOR USE. ISI DID RECEIVE THE CARD CAGE TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM AND REPRODUCE THE CUSTOMER REPORTED COMPLAINT. THE CARD CAGE WAS INSTALLED AND TESTED ON AN IN-HOUSE TEST SYSTEM. THE SYSTEM STARTED UP FAILED WITH AN ERROR 31221 NODE PATIENT-SIDE POWER DISTRIBUTION (PPD) WHICH MEANS THE HARDWARE HIGH SIDE SWITCH FAULT FIELD PROGRAMMABLE GATE ARRAY (FPGA) LOGIC HAD DETECTED A FATAL LOSS OF POWER AND HIT THE FAULT REACTION LOGIC (FRL). THIS FAULT SHOWS THE FRL HAD BEEN HIT. SOFTWARE WILL LOG A FAULT BEFORE OR AFTER THIS THAT SHOWS WHICH HIGH SIDE SWITCH CAUSED THE FAULT. ARM 2 WAS RED, AND THE UNIVERSAL POWER DISTRIBUTOR (UPD) HAD FAILED - ALL THE ARMS HAD RED LIGHT EMITTING DIODES (LED). FA TESTED WITH UPD TEXT FIXTURE, AND SYSTEM STARTED UP WITHOUT ANY ERROR. RAN 50 POWER CYCLES AND ALL PASSED. ALL THE GANTRY MOTORS MOVED THE FULL RANGE OF MOTION WITHOUT ANY ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO STATE THEY WERE RECEIVING AN ERROR 31221. THE TSE REVIEWED LOGS AND VERIFIED ERROR ON ARMNET 2. THE TSE WALKED CUSTOMER THROUGH MULTIPLE POWER CYCLES WITH NO SUCCESS. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569208 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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