BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16812005 · Received April 25, 2023

    Report

    Report Number
    2955842-2023-12189
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    February 24, 2023
    Report Date
    April 5, 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
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DARKENED CHIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE FENESTRATION BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FINDING OF INSTRUMENT BIPOLAR YAW PULLEY/THERMAL DAMAGE BETWEEN EXPOSED ELECTRODE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE ON THE OUTSIDE OF THE YAW PULLEY. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT MOVED INTUITIVELY IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT DELIVERED ENERGY ON SEVERAL ATTEMPTS. COMMON CAUSES OF THE FAILURE MODE THERMAL DAMAGE BETWEEN THE EXPOSED ELECTRODE ON THE INSTRUMENT BIPOLAR YAW PULLEY ARE TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE FOR EXAMPLE BY INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATH. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS FOUND THE THERMAL DAMAGE BETWEEN THE EXPOSED ELECTRODE ON THE INSTRUMENT BIPOLAR YAW PULLEY. THERMAL DAMAGE AT OR NEAR THE BIPOLAR YAW PULLEY IS EVIDENCE OF ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATION BIPOLAR FORCEPS INSTRUMENT HAD DARKENED CHIP IN THE INNER SIDE OF THE HOUSING ON THE DISTAL END BY THE JAWS WHERE THE CABLE IS HOUSED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865668 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K11220808 0019 00886874119808

    Patients

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