BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18235185 · Received November 29, 2023

    Report

    Report Number
    2955842-2023-20648
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 2, 2023
    Report Date
    November 6, 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
    MX
    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 WAS ANALYZED AND FOUND THE PRIMARY FAILURE OF FUNCTIONAL TEST FAILURE FAILED CONTINUITY TEST TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT FAILED ELECTRICAL CONTINUITY TEST AND THERE IS NO OBVIOUS DAMAGE TO THE CONDUCTOR WIRE. THE HOUSING WAS REMOVED FOR INSPECTION AND FOUND THE CONDUCTOR WIRE WAS DISLODGED FROM THE CONNECTOR AT PROXIMAL END. RE-INSERTED THE CONDUCTOR WIRE AND PASSED ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS INSTALLED ON IN-HOUSE SYSTEM AND PASSED RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. ENERGY WAS DELIVERED WITHOUT ANY ISSUES ON IN-HOUSE SYSTEM. THE INSTRUMENT WAS RETESTED AND PASSED ALL IN-HOUSE TESTING ON BOTH ATTEMPTS. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO THERMAL DAMAGE WAS OBSERVED. ADDITIONAL OBSERVATION RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE THE CONDUCTOR WIRE DISLODGED FROM CONNECTOR AT BACK END. THE INSTRUMENT FAILED ELECTRICAL CONTINUITY TEST RE-INSERTED THE CONDUCTOR WIRE AND PASSED ELECTRICAL CONTINUITY TEST. THERMAL DAMAGE WAS OBSERVED. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE DAMAGE OF THE CONDUCTOR WIRE¿S INSULATION. THE CONDUCTOR WIRE'S INSULATION FOUND NICKED AT YAW PULLEY DISTAL WITH NO EXPOSED INTERNAL WIRE. NO MISSING PIECE OF INSULATION. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST (AFTER DISLODGED CONDUCTOR WIRE AT PROXIMAL END RE-INSERTED). MOREOVER, THE INSTRUMENT WAS FOUND TO HAVE SCRATCH MARKS/ABRASIONS ON THE EDGE A SURFACE OF THE BIPOLAR YAW PULLEY. THE SCRATCH MARKS/ABRASIONS WERE FOUND ON ONE SIDE OF THE BIPOLAR YAW PULLEY. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    CORRECTION: AN ADDITIONAL OBSERVATION RELATED TO THE CUSTOMER REPORTED COMPLAINT WAS IDENTIFIED. THE INSTRUMENT WAS FOUND TO HAVE THE CONDUCTOR WIRE DISLODGED FROM CONNECTOR AT BACK END. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. THE CONDUCTOR WIRE WAS RE-INSERTED AND THE INSTRUMENT THEN PASSED THE ELECTRICAL CONTINUITY TEST. NO THERMAL DAMAGE WAS OBSERVED (IT HAD PREVIOUSLY BEEN NOTED THAT THERE WAS THERMAL DAMAGE OBSERVED).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A BROKEN WIRE. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071694 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K10220330 0017 00886874119808

    Patients

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