BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 2233159 · Received September 2, 2011

    Report

    Report Number
    2955842-2011-00288
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE INSTRUMENT'S ENTIRE TUBE EXTENSION TO BE DISLODGED FROM THE MAIN TUBE. THE TUBE EXTENSION WALL WAS FOUND TO BE CIRCUMFERENTIALLY BROKEN AT THE BASE OF THE AXIAL KEYS, HOWEVER, NO PIECES ARE MISSING. ENGINEERING CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO EXCESSIVE SIDE LOADING OR OTHER TYPE OF MISHANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, AFTER THE COLPOTOMY AND WHILE USING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, THE SURGEON ATTEMPTED TO REMOVE THE PATIENT'S UTERUS TRANSVAGINALLY. THE INSTRUMENTS WERE THEN EXCHANGED TO SEW THE VAGINAL CUFF WHEN THE MCS INSTRUMENT WAS FOUND TO BE BROKEN AT THE INSTRUMENT WRIST. THE MCS INSTRUMENT COULD NOT BE REMOVED THROUGH THE CANNULA DUE TO THE BREAKAGE, AND THEREFORE, THE CANNULA AND INSTRUMENT HAD TO BE REMOVED FROM THE PATIENT. IT WAS NOTED THAT FRAGMENTS FELL INTO THE PATIENT AND WERE REMOVED. NO PATIENT HARM, INJURY OR ADVERSE OUTCOME WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10101122 992

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES & ES