BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1133562 · Received August 22, 2008

    Report

    Report Number
    2955842-2008-01229
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONFIRMED THAT THE DISTAL END OF THE MAIN TUBE HAS MULTIPLE SECTIONS, 180 DEGREES APART, WITH VARYING DEGREES OF MATERIAL REMOVED. ONE AREA IS 1.7 INCHES LONG AND PARALLEL TO THE TUBE AXIS WITH LIGHT MATERIAL REMOVED. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. THE OTHER DAMAGED AREA APPEARS TO BE A COMBINATION OF TUBE ABRASIONS AND SCRATCH MARKS, MOST LIKELY FROM INSTRUMENT COLLISIONS. THIS SECTION HAS A ROUGHER SURFACE FINISH WITH HEAVY MATERIAL REMOVED. NO OTHER DAMAGE FOUND. THE ENDOWRIST INSTRUMENT 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 NO 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. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHAFT OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT IS ROUGH AND SCRATCHED. 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 MARYLAND BIPOLAR FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420172-06 209071 814

    Patients

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