BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1170804 · Received September 12, 2008

    Report

    Report Number
    2955842-2008-01267
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED PERFORMANCE TESTING AND FOUND THE INSTRUMENT TO BE SUCCESSFULLY RECOGNIZED BY A DA VINCI S SYSTEM. THE POGO PINS DO NOT STICK AND ARE NOT CONTAMINATED. ENGINEERING COULD NOT REPLICATE THE CUSTOMER REPORTED RECOGNITION ISSUE. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE TO HAVE VARIOUS SCRATCH MARKS CONCENTRATED IN A 1.6" LONG SECTION ON ONE SIDE OF THE TUBE. A FEW SCRATCHES ARE DEEP ENOUGH TO HAVE REMOVED TUBE MATERIAL. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS AND OR 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 THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT RECOGNIZED BY THE DA VINCI S SYSTEM. NO ADDITIONAL INFO WAS PROVIDED. NO PATIENT 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 420205-03 1904071 377

    Patients

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