BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24478304 · Received March 2, 2026

    Report

    Report Number
    2955842-2026-13904
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    November 23, 2024
    Report Date
    February 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT INVOLVED IN THIS COMPLAINT HAS BEEN RECEIVED AND TESTED BY FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A DAMAGED GRIP CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PROGRASP FORCEPS GAD A BROKEN WIRE AT THE WRIST. THERE WERE NO DELAYS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543025 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K12240530 0449 00886874119785

    Patients

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