BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21724046 · Received March 28, 2025

    Report

    Report Number
    2955842-2025-11369
    Event Type
    Injury
    Date Received
    March 28, 2025
    Date of Event
    February 14, 2025
    Report Date
    February 28, 2025
    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
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED; THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A PLANNED DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION PROCEDURE, THE INTEGRATED TABLE MOTION (ITM) TABLE CAUGHT FIRE, RESULTING IN A MINOR BURN TO THE SURGEON. THE CAUSE OF THE FIRE IS UNKNOWN; HOWEVER, THE SURGEON DOES NOT BELIEVE THAT A DA VINCI SYSTEM, INSTRUMENT, AND/OR ACCESSORY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS INCIDENT OCCURRED AFTER THE TRANSFER OF THE PATIENT TO THE ITM TABLE AND THE PLACEMENT OF PORTS. THE PATIENT WAS NOT INJURED. THE HOSPITAL WAS UNABLE TO PROVIDE DETAILS REGARDING ANY MEDICAL INTERVENTIONS THAT MAY HAVE BEEN PERFORMED OR THE SEVERITY OF THE SURGEON'S INJURY. CONSEQUENTLY, THE PATIENT WAS RELOCATED TO ANOTHER ROOM, AND THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613367 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

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