BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21455603 · Received February 25, 2025

    Report

    Report Number
    2955842-2025-02064
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    January 24, 2025
    Report Date
    January 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874114817
    PMA / PMN Number
    K162973
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE SUCTION IRRIGATOR INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUCTION IRRIGATOR INSTRUMENT WAS UNABLE TO BE REMOVED FROM PORT. UPON INSPECTION ON THE SCREEN, A PIECE OF METAL ON THE UNIT WAS STICKING OUT THAT CAUGHT THE TROCAR AND PREVENTED THE UNIT FROM BEING DISENGAGED. THE INTUITIVE REP IN THE ROOM ADVISED REMOVING THE TROCAR AND INSTALLING A NEW ONE. THE IRRIGATOR WAS THEN REMOVED FROM THE PORT MANUALLY BY THE NURSE AFTER PICTURES WERE TAKEN SHOWING THE METAL THAT WAS BEING CAUGHT ON THE TROCAR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS A METAL PART STICKING OUT BY THE WRIST. NO FRAGMENTS FELL INTO THE PATIENT'S ANATOMY. THE PORT SIZE WAS NOT INCREASED IN ORDER TO REMOVE THE INSTRUMENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO VISIBLE DAMAGE OR ANYTHING OUT OF THE ORDINARY APPEARED ON THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394819 ENDOWRIST SUCTION IRRIGATOR NAY INTUITIVE SURGICAL, INC 480299-06 K14241003 0299 10886874114817

    Patients

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