BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1063559 · Received June 20, 2008

    Report

    Report Number
    2955842-2008-01091
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Report Date
    June 20, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE BIPOLAR INSERT WAS MISSING FROM THE INSTRUMENT BACK END. AS A RESULT, THE BIPOLAR PINS WERE NO LONGER RETAINED AND THE CONDUCTOR WIRES STICK OUT OF THE CHASSIS. ENGINEERING ALSO OBSERVED THAT ONE SIDE OF THE DISTAL END OF THE MAIN TUBE HAS VARIOUS DEEP SCRATCHES WITH MATERIAL REMOVED. BASED ON THE LOCATION AND APPEARANCE, ENGINEERING DETERMINED THAT THE SCRATCHES WERE MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS. 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 CABLES WERE STICKING OUT AND FIBERGLASS WAS COMING OFF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. NOTHING WAS OBSERVED FALLING INTO THE PT. NO ADDITIONAL INFO WAS PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420172-06 0801082 962

    Patients

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