BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24328290 · Received February 12, 2026

    Report

    Report Number
    2955842-2026-04212
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    November 20, 2025
    Report Date
    February 12, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874121504
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE PROXIMAL CLEVIS DISLODGED. THE DISLODGED PROXIMAL CLEVIS IS ATTACHED TO THE MAIN TUBE. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN MAIN TUBE AT THE DISTAL TIP. A PIECE MEASURING AT APPROXIMATELY 3.77 MM X 2.68 MM WAS MISSING AND NOT RETURNED. THE COMPLAINT REGARDING THE INSTRUMENT WAS DIFFICULT TO REMOVED AND RESULTED IN A DISLOCATED WRIST OF THE INSTRUMENT, WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE. APPLYING EXCESSIVE FORCE ON THE DISTAL END OF THE INSTRUMENT DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL CAN CAUSE DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT COULD NOT BE REMOVED FROM THE CANNULA. IT WAS REMOVED FORCIBLY, WHICH RESULTED IN THE WRIST OF THE INSTRUMENT DISLOCATING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT INSTRUMENT BEING DIFFICULT TO REMOVE, WAS PROBABLY DUE TO THE WRIST NOT BEING FULLY STRAIGHTENED AS RECOMMENDED AND THE REMOVAL ANGLE WAS NOT THE RIGHT ONE. THE PROBLEM WAS NOT RELATED TO THE ARM OR TO THE DV CANNULA, BECAUSE WHEN CUSTOMER CHANGED THE INSTRUMENT FOR THE NEXT ONE EVERYTHING WAS WORKING PERFECTLY. THE DIFFICULTIES TO REMOVE THE INSTRUMENT THROUGH/ FROM THE CANNULA WAS ONLY WITH THIS ONE, WITH THE OTHER INSTRUMENT EVERYTHING WAS SMOOTH. THE INSTRUMENT WAS NOT REMOVED TOGETHER WITH CANNULA. REPORTER RE-CONFIRM THERE WAS NO FRAGMENT FALLING INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387526 ENDOWRIST LARGE SUTURE CUT NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 471296-10 K10240926 0132 00886874121504

    Patients

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