BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24644352 · Received March 19, 2026

    Report

    Report Number
    2955842-2026-16785
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    December 18, 2025
    Report Date
    March 19, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ONE BLADES BROKEN AT THE BASE. A PIECE APPROXIMATELY 2 MM X 9 .62 MM WAS FOUND TO BE BROKEN OFF, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT. COMPONENTS ADJACENT TO THIS BROKEN BLADE DO NOT SHOW DAMAGE. COMMON CAUSES OF THE FAILURE MODE BROKEN INSTRUMENT BLADES ARE ATTRIBUTED TO USE CONDITIONS. BROKEN BLADES RESULT FROM DAMAGE CAUSED BY CONTACT WITH OTHER INSTRUMENTS OR OTHER HARD/METAL OBJECTS (E.G., STAPLES, CLIPS, ETC.) DURING USE WHILE THE INSTRUMENT IS ACTIVATED. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. BLADE FRACTURES PROPAGATE FROM INITIAL CONTACT SITES DUE TO THE ULTRASONIC VIBRATION OF THE HARMONIC ACE BLADE, LEADING TO EVENTUAL/PREMATURE FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199426 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-10 K10250717 0180 10886874112738

    Patients

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