BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 1191239 · Received September 26, 2008

    Report

    Report Number
    2955842-2008-01291
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED PERFORMANCE TESTS AND FOUND THAT THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. RECOGNITION AND ENGAGEMENT PASSED. ENGINEERING ALSO OBSERVED THE DISTAL END OF MAIN TUBE HAS A 1.85" LONG SECTION, EXTENDING FROM THE INTERSECTION BETWEEN THE PROXIMAL CLEVIS AND THE MAIN TUBE TOWARD THE HOUSING, WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE DAMAGED AREA HAS A ROUGH SURFACE FINISH. 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 RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PK DISSECTING FORCEPS INSTRUMENT WAS NOT WORKING PROPERLY. 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 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420227-02 0711011 982

    Patients

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