BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24822831 · Received April 8, 2026

    Report

    Report Number
    2955842-2026-20852
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    November 25, 2025
    Report Date
    April 8, 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. FOR CLARIFICATION, THE CUSTOMER REPORTED COMPLAINT OF "CAN'T USE" WAS CONFIRMED AS A MISSING TEFLON PAD. THE HARMONIC ACE INSTRUMENT WAS ANALYZED, AND THE CLAMP ARM WAS FOUND TO HAVE COMPLETELY MISSING TEFLON PAD. A PIECE MEASURING APPROXIMATELY 11.0 MM X 2.65 MM WAS FOUND TO BE MISSING, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT. THE MISSING TEFLON PAD WAS NOT RETURNED. ADDITIONAL UNRELATED OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE(S) AT THE MIDPOINT 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. BLANK MDR FIELDS: 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 A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT FAILED TO EXCITE. SITE USED BACKUP HARMONIC ACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340932 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-10 L82240725 0134 10886874112738

    Patients

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