BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20053648 · Received August 23, 2024

    Report

    Report Number
    2955842-2024-18441
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 31, 2024
    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
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE YAW PULLEY. NO CONDUCTOR WIRE DAMAGE WAS OBSERVED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED THE BUMPER TEST. THE BIPOLAR ENERGY CORD WAS CONNECTED TO AN IN-HOUSE ERBE GENERATOR AND PASSED RECOGNITION AS AN ENERGY DEVICE IN SEVERAL POSITIONS. ENERGY DELIVERY WAS TESTED AND PASSED IN VARIOUS GRIP ORIENTATIONS. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE CENTRAL PROCESSING, THE PLASTIC JOINT AT THE FUNCTIONAL PART AT THE FRONT OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO BE DEFECTIVE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION ON THE REPORTED ISSUE; HOWEVER, NO FURTHER ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698041 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K11230323 0254 00886874119808

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES