BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23263354 · Received October 10, 2025

    Report

    Report Number
    2955842-2025-41256
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    October 2, 2025
    Report Date
    January 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ENGAGEMENT FAILURE. THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND FAILED THE MECHANICAL ENGAGEMENT SEQUENCE. THE INSTRUMENT INPUTS FAILED TO ENGAGE WITH THE IN-HOUSE SYSTEM'S STERILE ADAPTER DURING MULTIPLE ATTEMPTS. DUE TO ENGAGEMENT FAILURE, FUNCTIONAL TESTING FOR MOTION AND CLIP TEST COULD NOT BE PERFORMED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. ONCE THE INSTRUMENT IS RECOGNIZED ON THE DA VINCI SYSTEM, ENGAGEMENT GETS CHECKED. THE ENGAGEMENT SEQUENCE RUNS FOR EACH INSTALLATION OF THE INSTRUMENT TO ENSURE PROPER MATING AND TRANSMISSION OF FORCE BETWEEN USM CARRIAGE OUTPUTS, INSTRUMENT STERILE ADAPTER, AND INSTRUMENT INPUT DISKS. SUCCESSFUL ENGAGEMENT IS DETECTED BY DRIVING THE INSTRUMENT STERILE ADAPTER THROUGH A PREDEFINED TRAJECTORY. THE PROBABLE ROOT CAUSE OF ENGAGEMENT FAILURES IS ATTRIBUTED TO AN OVER-CONSTRAINED DESIGN CONDITION BETWEEN THE MATING PARTS OF THE INSTRUMENT AND INSTRUMENT STERILE ADAPTER DISKS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. 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 DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE 8MM LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS INSERTED, A CLIP WAS IN THE PROCESS OF BEING DEPLOYED BUT INSTRUMENT COULD NOT CLAMP DOWN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315385 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 K11230103 0058

    Patients

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