BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24528227 · Received March 6, 2026

    Report

    Report Number
    2955842-2026-15215
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    January 11, 2026
    Report Date
    May 28, 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
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 8MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT PROXIMAL END NEAR THE MAIN TUBE AND ROLL GEAR JUNCTION. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. NO SIGNS OF THERMAL DAMAGE WERE OBSERVED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THE CONDUCTOR WIRE BEING BROKEN ON THE PROXIMAL END IS ATTRIBUTED TO THE MANUFACTURING PROCESS. BREAKAGE CAN RESULT FROM PINCHED OR KINKED WIRES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WOULD NOT DELIVER ENERGY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ARCING WAS OBSERVED DURING THE PROCEDURE. NO OTHER INSTRUMENTS WERE IMPLICATED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612183 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K11250828 0024 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1