BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19924631 · Received August 6, 2024

    Report

    Report Number
    2955842-2024-17625
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 9, 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
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS RETURNED TO FAILURE ANALYSIS FOR ERROR 319. IT WAS CONFIRMED AND REPLICATED. THE UNIT WAS TESTED ON IN-HOUSE SYSTEM WHERE IT FAILED NORMAL MODE DUE TO ERROR 319 POINTING TO THE AXES CONTROLLER CARRIAGE (ACC). THE UNIT WAS ALSO TESTED ON AN IN-HOUSE PSC FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED FIBER TEST FOR THE ROLLING LOOP WITH 319 ALSO POINTING TO THE ACC. A GOLD ROLLING LOOP FIBER WAS INSTALLED TO TROUBLESHOOT WITH PASSING RESULTS.

    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 REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS; HOWEVER, THE INVESTIGATION IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THEY ENCOUNTERED A RECOVERABLE FAULT AND UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WAS DISABLED. THE TSE REVIEWED THE SYSTEM LOGS AND VERIFIED ERRORS 319 AND 307 ON USM 3. PRIOR TO CONTACTING THE TSE, THE CUSTOMER HAD DISABLED USM 3 TO CONTINUE WITH THREE USMS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. THE CUSTOMER CONTACTED ISI TECHNICAL SUPPORT AFTER THE PROCEDURE TO PERFORM TROUBLESHOOTING. THE TSE HAD THE CUSTOMER HARD POWER CYCLE THE SYSTEM AND PERFORM AN EMERGENCY POWER OFF (EPO), BUT THE ERROR PERSISTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM DID INITIALLY POWER ON WITHOUT ERRORS. THE CUSTOMER RESTARTED THE SYSTEM TWICE AND WHEN THE USM STILL DID NOT FUNCTION THE CUSTOMER MOVED FORWARD WITH THE CASE WITH THREE USMS. THE SURGEON DID DISABLE OR DISCONTINUE USE OF THE USM DUE TO THE ISSUE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH 3 USMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220233 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES