BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19389090 · Received May 23, 2024

    Report

    Report Number
    2955842-2024-14992
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    April 23, 2024
    Report Date
    April 23, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10 CONCOMITANT PRODUCTS: ERBE VIO DV 2.0 INTEGRATED ELECTROSURGICAL UNIT, PRODUCT MATERIAL # 951300-03, SERIAL NUMBER (B)(6). THE ERBE GENERATOR (OEM) IS INTEGRATED WITH THE DAVINCI VISION SIDE CART. THE PROCEDURE WAS AN OPEN APPENDECTOMY AND NO OTHER DAVINCI ROBOTIC CARTS OR PRODUCTS WERE USED. THE ERBE IESU GENERATOR WAS NOT MADE AVAILABLE TO THE FIELD SERVICE ENGINEER FOR EVALUATION. THE DAVINCI VISION SIDE CART WITH THE NEWLY INSTALLED ERBE GENERATOR PASSED TESTING AND WAS VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DAVINCI VISION SIDE CART'S ERBE VIO DV 2.0 INTEGRATED ELECTROSURGICAL UNIT (ERBE IESU) WAS USED DURING A NON-ROBOTIC, OPEN APPENDECTOMY PROCEDURE. AN OR NURSE INFORMED INTUITIVE SURGICAL TECHNICAL SUPPORT THAT DURING THE OPEN PROCEDURE "THEY HAD A POSSIBLE BURN WITH THE ERBE IESU...IT MAY HAVE BURNED THE PATIENT." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER SITE HAVE NOT BEEN SUCCESSFUL. AN INTUITIVE SURGICAL FIELD SERVICE ENGINEER (FSE) FOUND THAT THE ERBE HAD ALREADY BEEN REMOVED FROM THE DAVINCI VISION SIDE CART. THE UNIT WAS SECURED IN THE BIOMEDICAL ENGINEERING DEPARTMENT AND WAS WAS NOT MADE AVAILABLE FOR THE FSE TO PERFORM SYSTEM VERIFICATION AND ELECTRICAL SAFETY EVALUATIONS. A NEW ERBE IESU WAS INSTALLED IN THE VISION SIDE CART AND THE UNIT PASSED SYSTEM VERIFICATION AND ELECTRICAL SAFETY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664291 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-45 00886874110898

    Patients

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