BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23529855 · Received November 12, 2025

    Report

    Report Number
    2955842-2025-44843
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM PERMANENT CAUTERY HOOK INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE CERAMIC SLEEVE DISLODGED FROM ITS NORMAL POSITION ON THE YAW PULLEY. CERAMIC SLEEVE DOES NOT HAVE MISSING MATERIAL. THERE WAS MINIMAL SILICONE ADHESIVE ON THE YAW PULLEY AND INSIDE THE CERAMIC SLEEVE. THE PROBABLE ROOT CAUSE OF A DISLODGED CERAMIC SLEEVE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. INSUFFICIENT SILICONE POTTING ON THE CERAMIC SLEEVE CAN RESULT IN ITS DISLODGEMENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM PERMANENT CAUTERY HOOK INSTRUMENT HAD A BLACK BROKEN PART NEAR THE TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933055 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 N11210208 0002 00886874112311

    Patients

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