BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 25105264 · Received May 6, 2026

    Report

    Report Number
    2955842-2026-24058
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    December 17, 2025
    Report Date
    May 6, 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. THE HARMONIC ACE INSTRUMENT WAS ANALYZED, AND THE FINDINGS DID NOT REPLICATE OR CONFIRM THE CUSTOMER REPORTED RECOGNITION ISSUE. THE INSTRUMENT PASSED THE MANUAL ARTICULATION OF INPUTS. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT PASSED THE INITIALIZATION TEST. THE INSTRUMENT PASSED THE ENERGY DELIVERY TEST. THE LOGS WERE NOT AVAILABLE. FAILURE ANALYSIS COULD NOT VERIFY THE CUSTOMER REPORTED EVENT. ADDITIONAL UNRELATED OBSERVATION(S) NOT REPORTED BY SITE: THE CLAMP ARM WAS FOUND TO HAVE MELTING AND BREAKAGE OF THE TEFLON PAD AT THE TIP, THE MIDPOINT AND THE BASE. THE COMPONENT WAS DAMAGED AND THERE MAY BE MISSING MATERIAL, BUT THE SIZE OF THE MISSING PIECES CANNOT BE CONFIRMED. SEPARATED PIECE(S) WERE NOT RETURNED. FURTHER, THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE(S) AT THE TIP OF THE CURVED BLADE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION (APR) SURGICAL PROCEDURE, THE SYSTEM WAS UNABLE TO RECOGNIZED THE HARMONIC ACE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354637 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L81231109 0012 10886874112738

    Patients

    Seq Age Sex Outcome Treatment
    1