BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1220097 · Received October 31, 2008

    Report

    Report Number
    2955842-2008-01344
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Report Date
    October 31, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE GRIPS ARE NOT BENT AND THE GRIP TEETH PROPERLY MESH. ONE OF THE CONDUCTOR WIRES IS DAMAGED NEAR THE YAW PULLEY EXIT. THE INSULATION HAS BEEN CUT, EXPOSING BARE WIRE. THERE IS A CHAR MARK ON THE CONDUCTOR CAP NEAR THE DAMAGED WIRE, LIKELY CAUSED BY ENERGY ESCAPING THROUGH THE BARE WIRE AND ARCING TO THE CAP. ENGINEERING ALSO OBSERVED VARIOUS DEEP SCRATCHES WITH MATERIAL REMOVED ON ONE SIDE OF THE MAIN TUBE. THE SCRATCHES ARE NOT ALIGNED WITH THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGES ARE LIKELY CAUSED BY INSTRUMENT COLLISIONS/ROUGH HANDLING. 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 AT THE END OF A DA VINCI S SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS NOT WORKING PROPERLY AND THE TIP WAS BENT. NOTHING WAS SEEN FALLING INTO THE PATIENT. 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 S10080911 586

    Patients

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