BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST PROGRASP FORCEPS INSTRUMENT

    MDR report key: 1052761 · Received May 27, 2008

    Report

    Report Number
    2955842-2008-01026
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Report Date
    May 23, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE INSTRUMENT WAS RETURNED WITH THE HOUSING AND LEVERS MISSING. ENGINEERING CONCLUDED THAT THE HOUSING AND LEVERS LIKELY CAME OFF DUE TO MISHANDLING OF INSTRUMENT. ENGINEERING ALSO OBSERVED THAT DISTAL END OF MAIN TUBE HAS A 2.5 INCH LONG BY .125 INCH WIDE SECTION WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE DAMAGED AREA IS PARALLEL TO TUBE AXIS AND HAS A ROUGHER SURFACE FINISH THAN THE REST OF THE TUBE. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOUSING OF THE ENDOWRIST PROGRASP FORCEPS 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 ENDOWRIST PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420093-07 0801032 085

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESORIES| DA VINCI S SURGICAL SYSTEM