BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1022772 · Received March 28, 2008

    Report

    Report Number
    2955842-2008-00178
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    November 27, 2007
    Report Date
    March 28, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THAT ONE GRIP IS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE IS A .045 INCH OFFSET AT THE TIPS. THE BENT GRIP HAS A SLIGHT SEPARATION OF THE YAW PULLEY AND CONDUCTOR CAP AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. ELECTRICAL CONTINUITY PASSED. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAS VARIOUS DEEP SCRATCH MARKS WITH MATERIAL REMOVED. THE TUBE HAS VARIOUS RANDOMLY ORIENTED SCRATCHES AND ONE DAMAGED SECTION THAT IS NEARLY PARALLEL TO THE TUBE AXIS INDICATING THAT SCRATCHES ARE LIKELY DUE TO INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) DOES CONTAIN A HANDLING PRECAUTION, AS IDENTIFIED IN THE FOLLOWING TEST: 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 DURING A DA VINCI S SURGICAL PROCEDURE, THE JAWS OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WERE MISALIGNED AND HAD A LACK OF GRASPING FUNCTIONALITY. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT. NO ADD'L INFORMATION WAS PROVIDED. NO PATIENT 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 GEI INTUITIVE SURGICAL, INC. 420172-06 1707071 660

    Patients

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