BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23734562 · Received December 5, 2025

    Report

    Report Number
    2955842-2025-47749
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 19, 2025
    Report Date
    March 9, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS 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 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.

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED AND/OR TESTED BY FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT DOES NOT FULLY CLOSE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390818 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.