BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23529811 · Received November 12, 2025

    Report

    Report Number
    2955842-2025-44708
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    July 14, 2025
    Report Date
    November 11, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THERMAL DAMAGE TO THE YAW PULLEY. THE YAW PULLEY WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING OF BOTH BIPOLAR YAW PULLEYS, IN THE SPACE BETWEEN THE GRIPS. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. FOR CLARIFICATION, THE MELTING (THERMAL DAMAGE) OF THE BIPOLAR YAW PULLEY HAS CAUSED THE CABLE CRIMP TO MOVE, THUS SUPPORTING THE CUSTOMER COMPLAINT OF "DROPOUT OR LOOSE CABLE"; THE GRIP CABLE CRIMPS HOLD THE GRIP CABLE IS PLACE INSIDE OF THE BIPOLAR YAW PULLEY. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THERMAL DAMAGE IS ATTRIBUTED TO CARBONIZED TISSUE ON THE GRIPS OF THIS BIPOLAR INSTRUMENT CREATING A CONDUCTIVE PATH DURING USE. THERMAL DAMAGE CAN ALSO RESULT DUE TO INADVERTENT ENERGY APPLICATION FROM A MONOPOLAR INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING (PRE-ANESTHESIA) A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD A DROPOUT OR LOOSE CABLE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950714 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-19 K10240919 0359 00886874119792

    Patients

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