BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 22141453 · Received June 4, 2025

    Report

    Report Number
    2955842-2025-23479
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    May 12, 2025
    Report Date
    May 15, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED.

    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 FOUND TO HAVE THE CURVED BLADE BROKEN AT THE TIP OF THE BLADE. A PIECE APPROXIMATELY 0.507" X 0.085" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DID NOT SHOW DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT WAS SUDDENLY BROKEN, THE FRAGMENT WAS TAKEN OUT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SURGICAL TASK BEING PERFORMED AT THE TIME OF THE FRAGMENT FALLING INSIDE THE PATIENT WAS GRASPING TISSUE. THE SURGEON THINKS IT COULD BE THE QUALITY OF THE INSTRUMENT THAT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT WAS IN USE FOR ABOUT HALF AN HOUR. THE SURGEON DID NOTICE THE ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING A SURGICAL PROCEDURE. THE FRAGMENT DID NOT FALL INSIDE OF THE PATIENT DURING THE INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE SURGICAL PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT THE WRIST WAS STRAIGHTENED, AND NO RESISTANCE WAS NOTICED. THERE WAS NO DAMAGE TO THE CANNULA OR THE INSTRUMENT AFTER THE EVENT OCCURRED. THE FRAGMENT WAS RETRIEVED BY AN ASSISTANT WITH OTHER FORCEPS. IT WAS CONFIRMED VISUALLY THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENTS. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WAS NO INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO FOREIGN OBJECTS. THE INSTRUMENT IS AVAILABLE FOR RETURN. THERE WERE NO IMAGES OR VIDEO RECORDINGS OF THE PROCEDURE AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587689 DA VINCI HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-10 L82240815 0131 10886874112738

    Patients

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