BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21706694 · Received March 27, 2025

    Report

    Report Number
    2955842-2025-10455
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 3, 2025
    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
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: THE PROCEDURE WAS CONVERTED DUE TO THE PATIENT'S ANATOMY. EXTENSIVE ADHESIONS WERE FOUND; THE PATIENT HAD A PREVIOUS SURGICAL PROCEDURE ON THEIR APPENDIX. THE SURGEON WENT INTO THE PROCEDURE ANTICIPATING THE POSSIBILITY THAT THE PROCEDURE WOULD NEED TO BE CONVERTED TO AN OPEN PROCEDURE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER REPORTED NO ISSUE WITH THE SYSTEM FUNCTIONALITY. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DA VINCI-ASSISTED APPENDECTOMY PROCEDURE, THE PROCEDURE WAS CONVERTED TO OPEN. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTING THE ISSUE WAS PRESENT IN THE CASE WITH THE SURGEON, WHO WAS PERFORMING AN APPENDECTOMY AND CAME TO THE REALIZATION THAT THEY WOULD NEED TO PERFORM AN ILEOSTOMY. THE SURGEON WAS REPORTEDLY TRAINED TO PERFORM THE ILEOSTOMY AND CONVERTED THE CASE TO OPEN. THERE WERE NO REPORTED MALFUNCTIONS OR ISSUES WITH THE DA VINCI ITSELF. THE PROCEDURE WAS CONVERTED TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432975 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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