BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 25131750 · Received May 9, 2026

    Report

    Report Number
    2955842-2026-24572
    Event Type
    Malfunction
    Date Received
    May 9, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 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
    KS
    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 A CURVED BLADE(S) BENT AT THE DISTAL END OF THE INSTRUMENT. THE BENDING OF THE CURVED BLADE CAUSED THE MISALIGNMENT WITH THE INSTRUMENT CLAMP ARM. THE BLADE WAS MISALIGNED BY 0.5 MM WITH RESPECT TO THE CLAMP-ARM. ADDITIONAL UNRELATED OBSERVATION(S) NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE(S) AT THE MIDDLE OF THE CURVED BLADE. THE BLADE DID NOT HAVE CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE. FURTHER, THE CLAMP ARM WAS FOUND TO HAVE BREAKAGE/MELTING AND DISLODGEMENT OF THE TEFLON PAD AT THE BASE. THE COMPONENT IS DAMAGED AND THERE MAY BE MISSING MATERIAL, BUT THE SIZE OF THE MISSING PIECE(S) CANNOT BE CONFIRMED. SEPARATED PIECE(S) WAS NOT RETURNED. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED, AND THE IMAGE OF THE INSTRUMENT IS CONSISTENT WITH THE ALLEGED ISSUE OF A BENT TIP. 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP JAW WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 22-MAR-2026: THE DAMAGE WAS ON THE PORTION OF THE DEVICE THAT ENTERS THE PATIENT (DISTAL END) WHERE THE TIP WAS OBSERVED BENT/MISALIGNED. NO MATERIAL WAS DETACHED OR MISSING FROM THE PORTION OF THE DEVICE THAT ENTERS THE PATIENT'S BODY. NO FRAGMENT FELL INSIDE PATIENT ANATOMY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525410 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-10 K10260108 0233 10886874112738

    Patients

    Seq Age Sex Outcome Treatment
    1