BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21854565 · Received April 17, 2025

    Report

    Report Number
    2955842-2025-15539
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 23, 2025
    Report Date
    March 25, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    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 BLADE DAMAGE AT THE MIDDLE OF THE BLADE. ONE OF THE BLADE EDGES WERE INDENTED. THE CUTTING EDGE DID NOT HAVE CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE OR CUTTING FAILURE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF NICKS AND GOUGES ON THE INSTRUMENT BLADES IS ATTRIBUTED TO USE-RELATED DAMAGE WHEN ATTEMPTING TO CUT INCOMPATIBLE MATERIAL (I.E., HARD OBJECTS SUCH AS BONE OR CARTILAGE) OR MISHANDLING THE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SITE COULD NOT CONTRIBUTE FURTHER TO ALL THIS BECAUSE THE ERROR WITH THE BROKEN SCISSORS WAS ONLY NOTICED IN THE CENTRAL STERILIZATION DEPARTMENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MONOPOLAR CURVED SCISSORS INSTRUMENT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA) TESTING AND THE FA IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT BROKE OUT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682100 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-21 K16241017 0214 00886874112298

    Patients

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