BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1071379 · Received July 7, 2008

    Report

    Report Number
    2955842-2008-01134
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE INSTRUMENT TO NOT GRASP WELL DUE TO ONE GRIP BEING SLIGHTLY BENT, CREATING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE IS A .030" OFFSET AT THE TIPS. THE BENT GRIP HAS A SLIGHT SEPARATION OF THE YAW PULLEY AND THE CONDUCTOR CAP AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE WITH MATERIAL REMOVED. THE SCRATCHES ARE NARROW, UNDER .250" LONG, AND NOT ALIGNED WITH THE TUBE AXIS, SUGGESTING THEY MAY HAVE BEEN CAUSED BY INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. 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 TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT DOES NOT CLOSE WELL. 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. 420205-01 1203071 821

    Patients

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