BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23111641 · Received September 22, 2025

    Report

    Report Number
    2955842-2025-38885
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 20, 2025
    Report Date
    November 19, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT EXHIBITED IMPRECISE MOTION IN THE YAW DIRECTION. THE GRIP TIPS MOVED WITHIN THE JOINT LIMITS AND IN THE COMMANDED DIRECTION, HOWEVER A LAG OR DELAY IN THE MOTION THAT WAS OBSERVED. THE PROBABLE ROOT CAUSE IN THIS CASE IS ATTRIBUTED TO THE COMPONENT SUSCEPTIBILITY TO DAMAGE. THE IMPRECISE MOTION IN THE YAW DIRECTION OF GRIP TIPS CAUSED THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    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 SURGICAL PROCEDURE, THE VESSEL SEALER INSTRUMENT HAD LIMITED MOBILITY AND REACTED IN REVERSE (INSTEAD OF MOVING TO THE LEFT, MOVING TO THE RIGHT). NO FRAGMENT FELL INTO PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, SERIOUS INCIDENT OUTCOME OR INJURY. THE ISSUE CAUSED A DELAY BETWEEN 15 AND 30 MINUTES. INTUITIVE FOLLOWED UP AND CONFIRMED THAT THERE WAS NO PATIENT INJURY DUE TO THE ERROR. REPLACEMENT INSTRUMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069047 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 K16250102 0155

    Patients

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