BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24318071 · Received February 11, 2026

    Report

    Report Number
    2955842-2026-04090
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 22, 2026
    Report Date
    March 10, 2026
    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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE DISCOLORATION ON BOTH THE BLADE SIDES TIPS. THE DISCOLORATION WAS NOT RESIDUAL SOIL AND DID NOT NEED TO BE COMPLETELY REMOVED. THE DARKENING WAS CAUSED BY IRON OXIDE AND WAS A CHEMICAL CHANGE IN THE BLADE MATERIAL AND NOT A RESULT OF MISHANDLING/MISUSE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO DAMAGE DURING USE OR REPROCESSING. IMPROPER CLEANING OR STERILIZATION TECHNIQUES USED IN REPROCESSING CAN CAUSE DISCOLORATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT'S CAUTERIZATION MARKINGS WERE NOT COMING OFF. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374883 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K12250904 0167 00886874112298

    Patients

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