BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 21105738 · Received January 8, 2025

    Report

    Report Number
    2955842-2025-00217
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 12, 2024
    Report Date
    December 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114742
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 ERBE INTEGRATED ELECTRO-SURGICAL UNIT (IESU) GENERATOR WAS ANALYZED AND THE REPORTED PROBLEM WAS ABLE TO BE CONFIRMED USING LOGS TO SEE THERE WERE VARIOUS X-8A ERRORS INCLUDING 1, 2 AND 3. UPON VISUAL INSPECTION THERE WERE NO ISSUES FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE ERBE WAS TESTED USING SYSTEM, UNIT CAUTERIZED AND RECOGNIZED PORTS/INSTRUMENTS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE TO INSTRUMENT DETECTION ISSUE IN THE ERBE PORT 2 CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. IN-HOUSE TESTING OF THE RETURNED PRODUCT REVEALED NO ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    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 INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PRODUCT HAS BEEN RECEIVED AND THE FAILURE ANALYSIS IS STILL IN PROGRESS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    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 SURGICAL PROCEDURE THAT A 2-8A ERROR OCCURRED AGAINST THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THAT THIS ERROR WAS OCCURRING BECAUSE THE IESU WAS NOT ABLE TO READ THE INSTRUMENT DATA. THE TSE ADVISED TO CHECK THE INSTRUMENT ENERGY CORD, OR TO TRY USING ANOTHER BIPOLAR PORT. THE CALLER STATED THAT THEY WERE GOING TO GET ANOTHER INSTRUMENT CABLE. THE PROCEDURE WAS REPORTEDLY BEING COMPLETED AS PLANNED, WITH NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610850 DA VINCI SP VISION SYSTEM CART NAY INTUITIVE SURGICAL, INC 380941-34 N/A 00886874114742

    Patients

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