BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20038385 · Received August 22, 2024

    Report

    Report Number
    2955842-2024-18465
    Event Type
    Injury
    Date Received
    August 22, 2024
    Report Date
    July 23, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO INSUFFICIENT PROCEDURAL INFORMATION, FURTHER INVESTIGATION CANNOT BE PERFORMED.

    Description of Event or Problem · 0

    DURING AN INTERVIEW WITH A SURGEON, IT WAS MENTIONED THAT THERE WAS AN UNSPECIFIED ISSUE THAT OCCURRED IN A GYNECOLOGY PROCEDURE. THERE WERE NO ADDITIONAL DETAILS PROVIDED REGARDING THE INCIDENT, POTENTIAL PATIENT IMPACT, OR ANY POTENTIAL MALFUNCTION OF AN INTUITIVE SURGICAL, INC. (ISI) DEVICE/SYSTEM. THE REPORTING SURGEON IS A GENERAL SURGEON. DURING FOLLOW UP WITH THE SITE'S ROBOTICS COORDINATOR, IT WAS STATED THAT THERE WAS NO RECORD OF THIS INCIDENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940374 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DA VINCI INSTRUMENTS AND ACCESSORIES