BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18254396 · Received December 4, 2023

    Report

    Report Number
    2955842-2023-20710
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    September 14, 2023
    Report Date
    November 7, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE PASSED THE RECOGNITION ENGAGEMENT, ELECTRICAL CONTINUITY AND ENERGY DELIVERY TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS. THE INSTRUMENT PASSED THE ENERGY DELIVERY AND ELECTRICAL CONTINUITY TEST. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADIAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS WAS NOT WORKING PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO OBTAINED ADDITIONAL INFORMATION RELATING THE COMPLAINT. A BACK-UP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633546 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K10230515 0172 00886874119808

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DA VINCI INSTRUMENTS AND ACCESSORIES