BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1041296 · Received May 9, 2008

    Report

    Report Number
    2955842-2008-00256
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND ONE SCISSOR BLADE BROKE OFF AT THE CROSS SECTION OF THE GRIP CABLE CRIMP. THE BROKEN BLADE WAS RETURNED. THE INTACT BLADE SHOWS SIGNS OF LIGHT PITTING ON THE NON-CUTTING EDGE, INDICATING POSSIBLE CORROSION WHICH MAY HAVE CAUSED CORROSIVE CRACKING, CAUSING THE BLADE FAILURE. LABORATORY ANALYSIS DISCOVERED CHLORINE PRESENT ON THE FRACTURE SURFACE, INDICATING THAT THE TIP BREAKAGE WAS DUE TO STRESS CORROSION CRACKING. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL INSTRUCTIONS, CLEANING THE INSTRUMENTS. DO NOT EXPOSE INSTRUMENTS TO HYDROGEN PEROXIDE (H202), BLEACH OR ALKALINE-BASED CLEANING AGENTS, AS THIS MAY RESULT IN INSTRUMENT DAMAGE. PROLONGED EXPOSURE TO EITHER ULTRASONIC CLEANING OR CLEANING AGENTS MAY RESULT IN INSTRUMENT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, WHILE THE SURGEON WAS ATTEMPTING TO CUT TISSUE WITH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, ONE HALF OF THE TIP BROKE OFF AND FELL INTO THE PATIENT. THE FRAGMENT WAS IMMEDIATELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT OF THE SAME TYPE, WITH APPROXIMATELY A 10 MINUTE DELAY. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420179-08 1406071 087

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| ELECTROSURGICAL UNIT| DA VINCI S SURGICAL SYSTEMS