BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23763803 · Received December 9, 2025

    Report

    Report Number
    2955842-2025-47890
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 14, 2025
    Report Date
    January 5, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE VESSEL SEALER EXTEND (VSE) INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA CONFIRMED AND REPRODUCED THE CUSTOMER REPORTED COMPLAINT. THE VSE INSTRUMENT WAS FOUND TO HAVE A GRIP RING DISLODGED. THE SCREW HEAD WAS DAMAGED. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS, AND IT MOVED INTUITIVELY WITH FULL RANGE OF MOTION ON THE PITCH IN ALL DIRECTIONS. THE GRIPS DID NOT OPEN. THE DISLODGED GRIP RING LIKELY CAUSED THE GRIPS TO NOT OPEN. THE GRIP OPEN LEVER WAS NOT FUNCTIONAL. THE GRIP RING MOVED FREELY UP AND DOWN GRIP THE GRIP DRIVE ADAPTER. FURTHER EVALUATION NOTED THE VSE INSTRUMENT HAD IMPRECISE MOTION DURING GRIPPING AND UN-GRIPPING TEST. 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 INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. THE JAWS FAILED TO CLOSE PROPERLY. THIS WAS CAUSED AS A RESULT OF DISLODGED GRIP RING. ADDITIONALLY, THE VSE INSTRUMENT WAS FOUND TO HAVE A MISSING INTEGRATED CORD. THE CORD WAS CUT AND NOT RETURNED.

    Additional Manufacturer Narrative · 0

    ADVANCE LOG REVIEWS WERE PERFORMED BY A FAILURE ANALYSIS ENGINEER (FAE): NO LOGS WERE FOUND FOR THE VESSEL SEALER EXTEND INSTRUMENT UNDER QUESTION. E-100 LOGS SHOW 4 SEAL EVENTS WITH 1 HIGH INITIAL STARTING IMPEDANCE ERROR. NOTHING IN THE LOGS POINTS TO THE CUSTOMER¿S COMPLAINT. THE INSTRUMENT WAS USED FOR 54 SECONDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WOULD NOT OPEN. NO FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE, AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE CUSTOMER: SHE BELIEVED THE SURGERY WAS EITHER ON (B)(6)2025 OR (B)(6)2025 BUT WAS NOT CERTAIN.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526081 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 K17240329 0254 10886874115661

    Patients

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