BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18585508 · Received January 26, 2024

    Report

    Report Number
    2955842-2024-10702
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    January 11, 2024
    Report Date
    January 11, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER EXTEND (VSE) WAS ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE AT THE DISTAL OR PROXIMAL END OF THE INSTRUMENT. THERE WERE NO SIGNS OF FOREIGN PARTICLES AT THE DISTAL END NEAR THE GRIPS OR INSIDE OF THE SNAKE WRIST. ALL GRIP PINS WERE SECURELY IN PLACE. THE CONDUCTOR WIRE AND SNAKE WRIST CABLES WERE SECURELY INTACT. ALL SEVEN CERAMIC DOTS WERE INSTALLED INSIDE OF THE JAWS. THERE WAS NO DAMAGE TO THE SNAKE WRIST. THE BLADE WAS MANUALLY EXTENDED AND RETRACTED WITHOUT ANY ISSUES. THERE WAS NO DAMAGE TO THE BLADE. 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 ON SEVERAL ATTEMPTS. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PROBLEM DETECTED. THERE WERE FOREIGN PARTICLES RETURNED WITH THE INSTRUMENT THAT SEEMS TO BE HAIR. THE FOREIGN PARTICLES WERE INSPECTED UNDER A MICRO VIEWER AND THERE WAS A HAIR FOLLICLE NOTED AT THE END OF THE FIBERS. DUE TO THE PARTICLES BEING RETURN DETACHED FROM THE INSTRUMENT, FAILURE ANALYSIS CANNOT VERIFY IF THESE PARTICLES WERE LOCATED ON THE INSTRUMENT. THERE WERE TWO TO THREE SMALL PARTICLES RETURNED DETACHED FROM THE INSTRUMENT. THERE WERE NO ADDITIONAL PARTICLES FOUND ON THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS USED FOR A SURGICAL TASK AND WAS OBSERVED TO HAVE PROTRUDING FIBERS IN THE ARTICULATING JOINT. THE FIBERS WERE REMOVED WITH A LAPAROSCOPIC NEEDLE DRIVER INSTRUMENT. THE VSE INSTRUMENT PERFORMED AS INTENDED THROUGHOUT THE PROCEDURE THE USER COMPLETED THE PROCEDURE USING THE SAME SYSTEM. THERE WAS NO REPORT FROM THE CUSTOMER THAT A FRAGMENT FROM THE INSTRUMENT FELL INTO THE PATIENT DURING THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953530 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K17231013 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.