BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25263471 · Received May 23, 2026

    Report

    Report Number
    2955842-2026-26183
    Event Type
    Malfunction
    Date Received
    May 23, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 22, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A MELTED BLADE TIP. VISUAL INSPECTION FOUND THE INSTRUMENT BLADE MELTED AT TIP. THE INSTRUMENT WAS PLACED A DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AN ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS DID NOT STRUGGLE TO BE OPENED OR CLOSED. THE INSTRUMENT RELEASED ENERGY AND BEGAN ARCING ALMOST IMMEDIATELY. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THE THERMAL DAMAGE IS PRIMARILY ATTRIBUTED TO THE USE CONDITIONS OF MONOPOLAR ENERGY IF THE LOWEST POWER OR EFFECT SETTING POSSIBLE IS NOT USED FOR THE MINIMUM TIME NECESSARY TO ACHIEVE THE DESIRED EFFECT. EXCESSIVE ENERGY USAGE CAN CAUSE MELTING OF THE BLADES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SCISSORS TIP MELTED INTO THE 8MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. A BACKUP INSTRUMENT WAS USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO ARCING OBSERVED. THERE WAS NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551316 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K11251031 0405 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES.