BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24644025 · Received March 19, 2026

    Report

    Report Number
    2955842-2026-16858
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 19, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. THE INSTRUMENT FAILED THE ENERGY DELIVERY TEST/THE ENERGY DELIVERY WAS VERY LOW. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN A DIRECTION. THE INSTRUMENT GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED THE ELECTRIC CONTINUITY TEST BUT FAILED THE ENERGY DELIVERY TEST. THE INSTRUMENT DELIVERED LOW ENERGY ON FIVE ATTEMPTS. THE INSTRUMENT WAS NOT FULLY FUNCTIONAL. ADDITIONALLY, THE INSTRUMENT YAW PULLEY AT DISTAL WAS FOUND TO BE THERMALLY DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT CAUTERIZING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO THERMAL DAMAGE WAS OBSERVED DURING THE PROCEDURE. NO ARCING WAS REPORTED. THERE IS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331477 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K10250515 0430 00886874119808

    Patients

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