BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 1061784 · Received June 13, 2008

    Report

    Report Number
    2955842-2008-01067
    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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED TESTS AND FOUND THAT RECOGNITION PASSED. ENGINEERING ALSO FOUND THE DISTAL END OF THE MAIN TUBE HAS A .75 INCH LONG SECTION BELOW THE MID POINT WITH VARIOUS SCRATCHES AND LIGHT MATERIAL REMOVED. BASED ON THE LOCATION AND APPEARANCE, THE SCRATCH IS MOST LIKELY DUE TO INSTRUMENT COLLISIONS. A SCRAPE MARK BELOW THE MID POINT OF THE DISTAL END OF THE MAIN TUBE WAS ALSO OBSERVED, MOST LIKELY CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE FOUND. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL 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 PK DISSECTING FORCEPS INSTRUMENT WAS NOT RECOGNIZED BY THE DA VINCI S SYSTEM. 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 PK DISSECTING FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420227-02 0801181 546

    Patients

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