BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 19995943 · Received August 15, 2024

    Report

    Report Number
    2955842-2024-18117
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 13, 2024
    Report Date
    July 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE WAS NO REPORT OF ANY MALFUNCTION OF AN INTUITIVE SURGICAL INC. (ISI) SYSTEM, INSTRUMENT OR ACCESSORY OCCURRING DURING THE PROCEDURE; THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. SYSTEM AND INSTRUMENT LOG REVIEW COULD NOT BE PERFORMED AT THIS TIME DUE TO INSUFFICIENT PROCEDURE INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED RADICAL PROSTATECTOMY AND LYMPHADENECTOMY PROCEDURE, THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THE PATIENT WAS DISCHARGED; HOWEVER, THE PATIENT RETURNED TO THE HOSPITAL ON POST-OPERATIVE DAY 4 WITH A POSSIBLE ISCHEMIC INJURY OF THE BRAIN. AFTER GETTING UP, THE PATIENT FELT UNWELL AND UNBALANCED; THE PATIENT EXPERIENCED A HEAD BRUISE FROM THE WALL, WITH TONIC MOVEMENT THAT LASTED JUST UNDER 1 MINUTE, WITHOUT CLONIC MOVEMENTS OR LOSS OF CONSCIOUSNESS. THE NEXT FEW MINUTES, THE PATIENT EXPERIENCED CONFUSION AND WAS HYPORESPONSIVE. IT WAS OBSERVED THAT THE PATIENT'S MOUTH TURNED UP A LITTLE AFTER THE EPISODE. A HEAD COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH REVEALED POORLY DEFINED HYPODENSITY IN THE CORTEX OF THE INSULA ON THE LEFT, WITH LOSS OF DIFFERENTIATION BETWEEN THE WHITE-GRAY MATTER; SUSPICIOUS FOR ISCHEMIC INJURY. ADDITIONALLY, THERE WAS A HYPERDENSITY IN THE M2 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY SUGGESTIVE OF HEMATIC THROMBUS.INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619943 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-46 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES