BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22661498 · Received July 30, 2025

    Report

    Report Number
    2955842-2025-31964
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 6, 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
    OTHER

    Narratives

    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 CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS. THE INSTRUMENT DOES NOT SHOW DAMAGE TO THE CONDUCTOR WIRE. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE COMPLAINT REGARDING A SPARK WAS CONFIRMED BY FAILURE ANALYSIS. COMMON CAUSES OF THERMAL DAMAGE IS ATTRIBUTED TO CARBONIZED TISSUE ON THE GRIPS OF THIS BIPOLAR INSTRUMENT CREATING A CONDUCTIVE PATH DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT SPARKED. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE YELLOW COVER OF THE INSTRUMENT WAS CHARRING. AT THE SAME TIME, A MARYLAND BIPOLAR FORCEPS, A FENESTRATED BIPOLAR FORCEPS, AND A CADIERE FORCEPS WERE IN USE. THE GENERATOR USED WAS A VIO3 OF AMCO (THIRD-PARTY GENERATOR). THE SETTINGS USED WERE CUT: 5, COAG:9. THE ARCING OCCURRED WHILE IN CONTACT WITH TISSUE, BUT THERE WAS NO INJURY TO THE PATIENT. IT IS BELIEVED THAT THE ARCING HAPPENED DUE TO THE USE OF A 3RD PARTY GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444401 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-19 K10241024 0017 00886874119792

    Patients

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