BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25156400 · Received May 12, 2026

    Report

    Report Number
    2955842-2026-24564
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    December 10, 2025
    Report Date
    May 12, 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
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE INSTRUMENT IS EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE 8MM PROGRASP FORCEPS INSTRUMENT EXHIBITED RANDOM MOVEMENTS. 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 SURGEON'S MOVEMENTS WERE NOT TRANSCRIBED CORRECTLY. (E.G., DISTANCE INTENDED DID NOT MATCH DISTANCE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384570 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-14 K11250123 0469 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1