BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20271268 · Received September 20, 2024

    Report

    Report Number
    2955842-2024-19776
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 5, 2024
    Report Date
    August 21, 2024
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS WAS ANALYZED, AND THE REPORTED EVENT WITH THE INSTRUMENT COULD NOT BE REPLICATED NOR CONFIRMED. THE ELECTRICAL CONTINUITY TEST WAS PERFORMED BETWEEN THE MAIN TUBE AND GRIP TIPS AS WELL AS THE MAIN TUBE AND ELECTRICAL PINS AT THE PROXIMAL END BOTH RESULTS WERE NO ELECTRICAL CONTINUITY FROM THE MAIN TUBE. BASED ON THE INVESTIGATION RESULTS, THE CUSTOMER REPORTED ISSUES MAY BE DUE TO OTHER FACTORS UNRELATED TO THE PRODUCT. FURTHERMORE, THE INSTRUMENT WAS FOUND TO HAVE SURFACE DEGRADATION ALONG THE ENTIRE LENGTH OF THE MAIN TUBE. UNDERLYING GLASS FIBERS OF MAIN TUBE ARE EXPOSED DUE TO DEGRADATION. THE CONDUCTOR WIRE WAS FOUND TO HAVE A RETRACTED INSULATION. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST WHICH ARE BETWEEN THE GRIP TIPS AND THE ELECTRICAL PINS AT THE PROXIMAL END. COMPONENTS ADJACENT TO THIS WIRE DO NOT SHOW DAMAGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE 8 MM MARYLAND BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS WAS ANALYZED, AND THE INITIAL FINDINGS WERE CONFIRMED. THE INSTRUMENT HAD THE INSULATION OF THE CONDUCTOR WIRE RETRACTED. NO BROKEN CABLES WERE FOUND ON THE INSTRUMENT. IT IS UNCLEAR WHAT COULD CAUSE THE INSULATION TO BE PULLED BACK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THERE WAS POSITIVE ELECTRICITY ON THE BLACK BODY PART OF THE MARYLAND BIPOLAR FORCEPS ARM. THE PROCEDURE IN WHICH THE INSTRUMENT WAS USED WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386975 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-16 K11211116 0850 00886874119792

    Patients

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