BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23023332 · Received September 11, 2025

    Report

    Report Number
    2955842-2025-37620
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 21, 2025
    Report Date
    December 24, 2025
    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
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D9, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PROGRASP FORCEPS INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THE INSTRUMENT WAS FOUND TO HAVE A BENT GRIP TIP TANG.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROCEDURE DATE, TIME AND SURGEON WERE NOT PROVIDED; THEREFORE, NO DA VINCI SYSTEM LOGS ARE AVAILABLE FOR REVIEW. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER SHOWS A PROGRASP FORCEPS INSTRUMENT AGAINST A WHITE BACKGROUND. FAILURE ANALYSIS ENGINEERING WOULD BE ABLE TO PROVIDE FURTHER INSIGHT INTO THE NATURE OF THE FAILURE MODE AND IDENTIFY THE SPECIFIC COMPONENT THAT HAS FAILED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE HINGE OF THE PROGRASP FORCEPS INSTRUMENT BECAME DETACHED. INITIALLY, THE PROGRASP FORCEPS INSTRUMENT FAILED TO MOVE TO THE DESIRED ANGLE, AND EFFORTS TO REMOVE IT RESULTED IN IT BECOMING STUCK IN THE CANNULA. AFTER REMOVING BOTH THE INSTRUMENT AND THE CANNULA TOGETHER, INSPECTION REVEALED THAT THE HINGE HAD DETACHED. ATTEMPTS TO RECONNECT THE HINGE WERE UNSUCCESSFUL. THE PROGRASP FORCEPS INSTRUMENT WAS SUBSEQUENTLY REPLACED WITH AN ALTERNATIVE INSTRUMENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2705952 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K11240104 0095 00886874119785

    Patients

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