BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 23963229 · Received January 5, 2026

    Report

    Report Number
    2955842-2025-50488
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    December 10, 2025
    Report Date
    March 18, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ONE BLADE BROKEN AT THE BASE. A PIECE MEASURING APPROXIMATELY 2.0 MM X 9 .50 MM IN SIZE 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 DID NOT SHOW DAMAGE.

    Additional Manufacturer Narrative · 0

    THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE HARMONIC ACE INSTRUMENT BROKE INTO TWO PIECES. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE WITH A PROCEDURE DELAY OF GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335764 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-12 K10250731 0164 10886874112738

    Patients

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