BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1232786 · Received November 14, 2008

    Report

    Report Number
    2955842-2008-01366
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Report Date
    November 14, 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 FOUND THE TOP PLUG RISER PIN TO BE PUSHED INTO THE BACK END, MAKING IT DIFFICULT FOR BIPOLAR CAUTERY TO BE FUNCTIONAL. THE CHASSIS FEATURE THAT RETAINS THE BIPOLAR INSERT AND PINS IS BROKEN. THE INSTRUMENT WAS MOST LIKELY MISHANDLED, BREAKING THE CHASSIS FEATURE. ELECTRICAL CONTINUITY PASSED. ENGINEERING ALSO FOUND THAT THE MAIN TUBE HAS A LARGE SECTION WITH MATERIAL REMOVED ALL AROUND THE TUBE FROM JUST BELOW MIDPOINT TO THE DISTAL END. THE DAMAGED AREA IS PARALLEL TO THE TUBE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY, HOWEVER, THE SIZE OF THE DAMAGED AREA IS LONGER THAN USUAL, SUGGESTING POSSIBLE ADDITIONAL TUBE DAMAGE OCCURRED DURING THE CLEANING PROCESS. NO OTHER DAMAGE FOUND. ADDITIONAL 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 FENESTRATED BIPOLAR FORCEPS INSTRUMENT WOULD NOT WORK. 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. 420205-04 0710191 309

    Patients

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