BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED MARYLAND BIPOLAR INSTRUMENT

    MDR report key: 1031314 · Received April 18, 2008

    Report

    Report Number
    2955842-2008-00212
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Report Date
    April 18, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THE DISTAL END OF MAIN TUBE HAS A 1 INCH LONG BY .200 INCH WIDE SECTION WITH LIGHT MATERIAL REMOVED. THE DAMAGED AREA STARTS ABOVE THE PROXIMAL CLEVIS AND IS PARALLEL TO THE TUBE LONGITUDINAL AXIS. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE FOUND. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A F/U MDR WILL BE SUBMITTED IF ADD'L INFO IS REC'D.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBERGLASS SHAFT OF THE FENESTRATED MARYLAND BIPOLAR INSTRUMENT IS SHREDDING. 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. 420172-02 0801171 430

    Patients

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