BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19076860 · Received April 9, 2024

    Report

    Report Number
    2955842-2024-13019
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 13, 2024
    Report Date
    March 15, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE PATIENT. REFER TO FIELD A2.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 8MM MONOPOLAR CURVED SCISSORS WAS ANALYZED AND REPORTED FAILURE WAS NOT CONFIRMED. THE VISUAL INSPECTION FOUND EXCESSIVE BIO DEBRIS ON THE SCISSOR TIPS WHICH PREVENTED THE TIPS FROM OPENING. THE BIO DEBRIS WAS REMOVED FROM THE TIP OF THE SCISSORS AND THE INSTRUMENT TIPS WERE ABLE TO BE MANUALLY OPENED. 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 TIPS OPENED AND CLOSED PROPERLY AND PASSED THE CUT TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE PRODUCT IS EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT BECAME CHARRED AND WOULD NOT OPEN. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418375 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K11231012 0616 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Unknown DA VINCI INSTRUMENTS AND ACCESSORIES