The device was received for investigation.During initial inner illumination test, partial blockage of the lumen was found.After cleaning the device the blockage was removed.Light passed through both sides of the restriction unit.Therefore, there is no indication for a manufacturing related factors that could cause the blockage.During production, 100% final inspection is being performed on the entire batch, including visual inspection and inner illumination.If a blockage would be noticed, the product would have been rejected immediately.Having said that, one may conclude that the blockage was formed after the product left the manufacturing plant.(b)(4).
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