BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    MDR report key: 3864237 · Received June 10, 2014

    Report

    Report Number
    2955842-2014-03555
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT THE CABLE ASSEMBLY WAS FOUND BROKEN AT THE SNAKE WRIST. THE BROKEN CABLE SEGMENTS WERE VARIOUS IN LENGTHS. THE MOTION WAS NO LONGER INTUITIVE DUE TO THE CABLE BREAKAGE. FAILURE ANALYSIS ALSO OBSERVED A DISLODGED SNAKE WRIST. NO PIECES WERE MISSING. THE DISLODGED SNAKE WRIST WOULD CAUSE DIFFICULTY OF REMOVING THE INSTRUMENT OUT OF THE CANNULA. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE CABLE DAMAGE AND/OR DISLODGED SNAKE WRIST, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VESSEL SEALER INSTRUMENT CABLE WAS NOTED TO BE BROKEN DOWN WHERE IT MOVES AND THE STAFF COULD NOT REMOVE THE INSTRUMENT OUT OF THE CANNULA DURING A DA VINCI PROSTATECTOMY PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338574 ENDOWRIST ONE VESSEL SEALER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 M10140113 556

    Patients

    Seq Age Sex Outcome Treatment
    1