BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1061785 · Received June 13, 2008

    Report

    Report Number
    2955842-2008-01065
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED TESTS AND FOUND THAT THE DA VINCI S SYSTEM INTERMITTENTLY RECOGNIZED THE INSTRUMENT. ENGINEERING DETERMINED A MECHANICAL INTERACTION BETWEEN THE CHASSIS, INPUT DISCS, AND STERILE ADAPTER IS RESULTING IN SLIGHT POSITIONING VARIATIONS OF THE POGO PINS AND CAUSING THE INTERMITTENT RECOGNITION ISSUES. ENGINEERING ALSO FOUND THE DISTAL END OF THE MAIN TUBE HAS DEEP SCRATCHES AND SCRAPE MARKS, APPROX 180 DEGREES APART, WITH MATERIAL REMOVED. THE SCRAPE MARK IS 1.25 INCHES LONG AND PARALLEL TO THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE THE SCRAPE MARK MOST LIKELY CAUSED BY A CANNULA ACCESSORY. THE OTHER SIDE OF THE TUBE HAS THREE ADJACENT DEEP SCRATCHES PERPENDICULAR TO THE TUBE AXIS, LIKELY CAUSED BY INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS: HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT "WOULD NOT ENGAGE IN ARM". NO ADD'L INFO WAS PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420205-03 2806071 729

    Patients

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