BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST PROGRASP INSTRUMENT

    MDR report key: 909221 · Received September 4, 2007

    Report

    Report Number
    2955842-2007-00307
    Event Type
    Malfunction
    Date Received
    September 4, 2007
    Report Date
    September 4, 2007
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED A SECTION ON THE DISTAL END OF THE INSTRUMENT MAIN TUBE WITH MATERIAL REMOVED, APPROXIMATELY 2" ABOVE THE PROXIMAL CLEVIS. IT WAS DETERMINED THAT THIS DAMAGE TO THE MAIN TUBE WAS MOST LIKELY CAUSED BY A DEFECTIVE CANNULA ACCESSORY. ENGINEERING ALSO OBSERVED A DEEP SCRATCH APPROX .5" ABOVE THE PROXIMAL CLEVIS. IT WAS DETERMINED THAT THE SCRATCH WAS MOST LIKELY CAUSED BY A COLLISION WITH ANOTHER INSTRUMENT. NO OTHER DAMAGE WAS FOUND. THE FOLLOWING MEDWATCH REPORTS WERE CREATED FOR THE DEFECTIVE CANNULAE PREVIOUSLY RETURNED FROM THIS SITE: 2955842-2006-000300, 2955842-2006-000301, 2955842-2006-000302, 2955842-2006-3003,2955842-2006-000304, 2955842-2006-000305.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDOWRIST PROGRASP INSTRUMENT HAD ABRASIONS ON ITS MAIN TUBE, WHICH WERE CAUSED BY A DEFECTIVE CANNULA. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE FOLLOWING MEDWATCH REPORTS WERE CREATED FOR THE INSTRUMENTS WITH RELATED COMPLAINTS USED AT THE SAME FACILITY. MFR. REPORTS: #2955842-2006-00306, 2955842-2006-00308, 2955842-2006-00309, 2955842-2006-00310, 2955842-2006-00311.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST PROGRASP INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420093-07 2206071 183

    Patients

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