BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19764907 · Received July 17, 2024

    Report

    Report Number
    2955842-2024-16847
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 20, 2024
    Report Date
    June 20, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS BEEN IMPLICATED OR RETURNED FOR FAILURE ANALYSIS (FA) EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE ROBOTIC PORTION OF A DA VINCI ASSISTED HYSTERECTOMY WAS COMPLETED, THE BLADDER WAS INJURED. THE INJURY OCCURRED AS THE SURGEON WAS VAGINALLY MORCELLATING THE UTERUS. THE END PORTION OF THE PROCEDURE WAS CONVERTED TO OPEN SURGERY, AND A UROLOGIST ASSISTED WITH THE BLADDER REPAIR. DURING FOLLOW UP WITH THE SURGEON, IT WAS CONFIRMED THAT THE ISSUE HAD NOTHING TO DO WITH A DA VINCI PRODUCT, AND THE PATIENT IS DOING WELL. HOWEVER, NO FURTHER DETAILS ON THE EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355047 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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