BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24275594 · Received February 6, 2026

    Report

    Report Number
    2955842-2026-03401
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 7, 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) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS FOUND THE PRIMARY FINDING OF INSTRUMENT BLADE DISCOLORATION TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE DISCOLORATION ON BOTH OF THE BLADE TIPS. THIS DISCOLORATION IS NOT RESIDUAL SOIL AND DOES NOT NEED TO BE COMPLETELY REMOVED. THIS DARKENING IS CAUSED BY IRON OXIDE AND IS A CHEMICAL CHANGE IN THE BLADE MATERIAL AND NOT A RESULT OF MISHANDLING/MISUSE. PROBABLE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, MONOPOLAR CURVED SCISSORS (MCS) EXHIBITED CAUTERIZATION MARKS THAT WILL NOT COME 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
    94880 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K18250904 0302 00886874112298

    Patients

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