BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22573438 · Received July 23, 2025

    Report

    Report Number
    2955842-2025-31202
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    February 4, 2025
    Report Date
    June 26, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE FORCE BIPOLAR INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MAIN TUBE APPROXIMATELY 46.55MM FROM THE DISTAL TIP. A PIECE MEASURING APPROXIMATELY 1.13MM X 3.81MM WAS NOT RETURNED WITH THE INSTRUMENT. COMPONENTS ADJACENT TO THIS BROKEN MAIN TUBE DO NOT SHOW DAMAGE. ADDITIONAL OBSERVATION RELATED TO CUSTOMER COMPLAINT : THE INSTRUMENT WAS FOUND TO HAVE DISLODGED PROXIMAL CLEVIS AT THE MAIN TUBE. THE ROOT CAUSE OF THE DISLODGED PROXIMAL CLEVIS ATTRIBUTED TO BROKEN MAIN TUBE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM AN ACCIDENTAL DROP OF THE INSTRUMENT OR INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS. EXCESSIVE SIDE LOADING ON THE INSTRUMENT CAN ALSO CAUSE THE MAIN TUBE WALL TO COLLAPSE INWARDS LEADING TO CRACKING AND SUBSEQUENT BREAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8MM FORCE BIPOLAR INSTRUMENT'S TIP SEPARATED AND POPPED OFF THE BODY PART OF THE INSTRUMENT. THE CUSTOMER FINISHED THE CASE WITH THE INSTRUMENT THAT WAS ALREADY IN USE. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED BUT THE PATIENT OUTCOME WAS NOT PROVIDED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2724746 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10231130 0009 00886874120767

    Patients

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