BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED MARYLAND BIPOLAR INSTRUMENT

    MDR report key: 1052759 · Received May 27, 2008

    Report

    Report Number
    2955842-2008-01024
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Report Date
    May 23, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE DISTAL TIP OF THE INSTRUMENT IS UNDAMAGED. THERE IS ONE BIPOLAR PIN AND PLUG RISER INSERT THAT ARE MISSING FROM THE BACK END OF THE INSTRUMENT. THE PIN WAS LIKELY PULLED OFF DURING REMOVAL OF A TIGHT FITTING BIPOLAR CORD. THE OTHER PIN IS PROPERLY CRIMPED. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAS A COUPLE OF DEEP SCRATCHES WITH LIGHT MATERIAL REMOVED. THE SCRATCHES ARE NOT ALIGNED WITH THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE SCRATCHES ARE MOST LIKELY DUE TO INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTION 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 TIP OF THE FENESTRATED MARYLAND BIPOLST INSTRUMENT IS BROKEN. 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 FENESTRATED MARYLAND BIPOLAR INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 400172-08 0712052 094

    Patients

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