BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23019402 · Received September 10, 2025

    Report

    Report Number
    2955842-2025-37452
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 11, 2025
    Report Date
    November 5, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS FOUND TO HAVE THE MAIN TUBE DISLODGED. THE MAIN TUBE METAL TABS WERE FOUND TO BE DISLODGED FROM THE SLOTS AT THE DISTAL END. AS A RESULT, THE INSTRUMENT FAILED PRECISE MOTION TEST. THE INSTRUMENT EXHIBITED IMPRECISE MOTION WHEN THE MASTER TOOL MANIPULATORS (MTM) WERE MANIPULATED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT EXHIBITED IMPRECISE MOTION IN THE WRIST DIRECTION DURING GRIPPING AND UN-GRIPPING. THE GRIP TIPS MOVED WITHIN THE JOINT LIMITS A IN THE COMMANDED DIRECTION, HOWEVER A LAG OR DELAY IN THE MOTION THAT WAS OBSERVED. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. ROOT CAUSE ATTRIBUTED TO DISLODGED MAIN TUBE. THE PROBABLE ROOT CAUSE OF A DISLODGED MAIN TUBE AND THE RESULTING IMPRECISE MOTION IS ATTRIBUTED TO DAMAGE DURING USE. WHEN THE ROLL GEAR TABS THAT MATE WITH THE MAIN TUBE AND PROVIDE A HARD STOP ARE DAMAGED, THE MAIN TUBE CAN ROTATE INDEPENDENTLY OF THE ROLL GEAR. THIS ROTATION CAN CAUSE A MISCALIBRATION BETWEEN THE MASTER TOOL MANIPULATOR (MTM) AND MAIN TUBE. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND INSTRUMENT WORKED OK INITIALLY. THE ERROR MESSAGE DISPLAYED "LASER EXPOSED DURING SURGERY"; FROM THIS POINT, THE INSTRUMENT FAILED TO WORK APPROPRIATELY. THE SURGEON REPORTED THAT THE INSTRUMENT WAS DOING ACTIONS THAT WERE OPPOSITE TO WHAT IT SHOULD HAVE BEEN, FOR EXAMPLE, GOING UPWARDS INSTEAD OF DOWNWARDS. THE INSTRUMENT WAS UNUSABLE FROM THIS POINT AND A SECOND INSTRUMENT WAS OPENED. THE PROCEDURE WAS COMPLETED WITH NO INJURY AND NO DELAYS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2517971 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 L11250109 0309 10886874115661

    Patients

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