Actual device returned for investigation on 12/21/2015.Product appeared to be used.Upon visual and functional testing, with a microscope and leak tester, hole was found about 3" from distal hose and broken bowden wire.Hole allowed moisture to penetrate into system making it hard for internal wires to glide and distal hose to flex.In addition, over time moisture causes wire to corrode and easily break when device is used.Unable to determine what made the hole in the distal hose.Not a manufacturing issue.When the deflection cable breaks, the hose goes flacid and does not whip backwards therefore there is minimal risk of injuring patient.No injuries to patient or staff were reported.Manufacture date: 10/15/2014.Purchase date: (b)(4) 2015.One similar complaint on this specific product by the same reporter in the last three years (mdr1418479-2013-00005).Initial reporter has be contacted in an effort to gather missing information (ie patient information.), no response as of 12/31/2015.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions.Rwmic considers this matter closed.However, in the event additional information is received, rwmic will provide fda with follow-up information.
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