BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24439452 · Received February 25, 2026

    Report

    Report Number
    2955842-2026-08603
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    December 23, 2025
    Report Date
    February 24, 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
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MAIN TUBE IN THE MIDDLE. A PIECE IN THE MIDDLE OF THE INSTRUMENT WAS FOUND TO BE MISSING AND WAS NOT RETURNED WITH THE INSTRUMENT. COMPONENTS ADJACENT TO THE BROKEN MAIN TUBE DID NOT SHOW DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM AN ACCIDENTAL DROP OF THE INSTRUMENT OR INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS. EXCESSIVE SIDE LOADING ON THE INSTRUMENT CAN ALSO CAUSE THE MAIN TUBE WALL TO COLLAPSE INWARDS LEADING TO CRACKING AND SUBSEQUENT BREAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT SHAFT SPLINTERED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT BROKE IN HALF. THERE WAS NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612937 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K13240920 0033 00886874119808

    Patients

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