BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25258129 · Received May 22, 2026

    Report

    Report Number
    2955842-2026-25901
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 22, 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
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE AT THE BASE. ONE BLADE EDGE WAS INDENTED CAUSING THE INSTRUMENT¿S SCISSORS TO NOT OPEN AND CLOSE PROPERLY. THERE MIGHT BE DETACHED FRAGMENTS THAT CAN'T BE RETRACED NOR MEASURED. PROBABLE ROOT CAUSE IS ATTRIBUTED TO USE RELATED DAMAGE WHEN ATTEMPTING TO CUT INCOMPATIBLE MATERIAL, SUCH AS HARD OBJECTS LIKE BONE OR CARTILAGE, OR FROM MISHANDLING OR MISUSING THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) BLADE HAS A CHIP IN IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109317 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K10251105 0311 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1