BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25283654 · Received May 26, 2026

    Report

    Report Number
    2955842-2026-26204
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    February 28, 2026
    Report Date
    May 26, 2026
    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
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE VESSEL SEALER EXTEND (VSE) INSTRUMENT TO PERFORM FAILURE ANALYSIS, AND THE COMPLAINT WAS CONFIRMED. THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS ANALYZED AND WAS PLACED ON THE IN-HOUSE SYSTEM AND THE BLADE FAILED TO RETRACT DURING INITIALIZATION CAUSING THE INSTRUMENT TO FAIL SELF-TEST. IN ADDITION, THE VSE INSTRUMENT WAS FOUND TO HAVE THE GRIP TORSION SPRING LOOSE/DISLODGED. AS A RESULT, THE GRIPS COULDN'T CLOSE FULLY DURING SELF-TEST, CAUSING THE BLADE TO GET EXPOSED. A VISUAL INSPECTION SHOWED THAT THE BLADE WAS EXTENDED 4.5 MM OUTSIDE OF THE BLADE GARAGE. THERE WAS NO BIO DEBRIS FOUND AT THE INSTRUMENT TIP. A REVIEW OF SYSTEM LOGS SHOWED THE VESSEL SEALER EXTENDED FAILED 12 TIMES DURING THE HOMING ON UNIVERSAL SURGICAL MANIPULATOR 4 (USM4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT HAD AN EXPOSED BLADE AND COULD NOT BE USED FURTHER. THE SURGEON KNEW HOW TO USE THE INSTRUMENT AS THEY WERE A REGULAR USER OF THE VSE INSTRUMENTS AND WAS WELL AWARE OF THE TECHNICAL DETAILS. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288074 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 K13251109 0378 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1