BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24622065 · Received March 17, 2026

    Report

    Report Number
    2955842-2026-16513
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 24, 2026
    Report Date
    May 5, 2026
    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
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THERMAL DAMAGE TO THE YAW PULLEY. THE YAW PULLEY WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE YAW PULLEY NEXT TO THE CONDUCTOR WIRE. THE INSULATION OF THE CONDUCTOR WIRE DO NOT SHOW DAMAGE. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE COMPLAINT REGARDING BURNT IN THE FRONT NEXT TO THE ROPE, WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THERMAL DAMAGE TO THE BIPOLAR YAW PULLEY CAN BE ATTRIBUTED TO INADVERTENT ENERGY APPLICATION FROM A MONOPOLAR INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER NOTED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO BE BURNT IN FRONT NEXT TO THE WIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, SERIOUS INCIDENT OR INJURY AND NO DELAYS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57112 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-19 K11250515 0273 00886874119792

    Patients

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