BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 25326900 · Received May 29, 2026

    Report

    Report Number
    2955842-2026-26841
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    December 4, 2025
    Report Date
    May 28, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS, AND THE COMPLAINT WAS CONFIRMED. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE BREAKAGE OF THE TEFLON PAD AT ITS TIP. A PIECE MEASURING APPROXIMATELY 5.0MM X 2.5MM WAS FOUND TO BE BROKEN OFF, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT. SEPARATED PIECE(S) WAS NOT RETURNED. ADDITIONAL UNRELATED OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE(S) AT ITS TIP. THE BLADE DID NOT HAVE CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE. THE PROBABLE ROOT CAUSE OF THE TEFLON PAD DAMAGE IS ATTRIBUTED TO USE CONDITIONS. DAMAGE IS CAUSED BY HEAT GENERATION WHEN ACTIVATING THE HARMONIC ACE BLADE WITH LITTLE TO NO TISSUE BETWEEN THE PAD AND THE BLADE ITSELF. THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED HYPOPHARYNGECTOMY SURGICAL PROCEDURE, THE BLADE HEAD GASKET/HARMONIC ACE INSTRUMENT EXPERIENCED RETRACTION. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202543 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-10 L11241127 0341 10886874112738

    Patients

    Seq Age Sex Outcome Treatment
    1