BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20639109 · Received November 8, 2024

    Report

    Report Number
    2955842-2024-21497
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 14, 2024
    Report Date
    October 14, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED, AND THE REPORTED PROBLEM WAS CONFIRMED. LOGS RECORDED ERROR 23000 COUPLED WITH ERRORS 23008, 23137 POINTING TO AXIS 1. UNIT WAS TESTED IN -HOUSE WHERE IT FAILED SENSORS CHECK AND SINE CYCLE WITH 23008 ERROR. NO SIGNS OF DAMAGE DURING INSPECTION.

    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 RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT ASSOCIATED WITH THE CUSTOMER-REPORTED COMPLAINT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ADRENALECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 KEPT ERRORING, THE SYSTEM RESTARTED WITH NO CHANGE. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED ERROR 23000, POINTING TO AXIS1 ON USM 3. THE TSE WALKED THE CUSTOMER THROUGH REPOSITIONING THE USM AND PERFORMING A HARD POWER SYSTEM, BUT THE ISSUES CONTINUED TO PERSIST. DUE TO THE CURRENT OPERATIONAL REQUIREMENTS, THE CUSTOMER WILL NEED ALL 4 USMS TO COMPLETE THE SCHEDULED CASE. THE CUSTOMER PLANS TO USE A PATIENT SIDE CART (PSC) FROM A DIFFERENT SYSTEM TO COMPLETE THE CASE. THE CUSTOMER WILL CALL BACK IF ASSISTANCE IS NEEDED WHEN SWAPPING OUT THE PSC. THE TSE COLLECTED ALL AVAILABLE INFORMATION, AND THE CALL ENDED. THE PROCEDURE WAS ABORTED TO ANOTHER DA VINCI SYSTEM WITH NO INDICATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849776 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-20 N/A

    Patients

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