A visual, functional and dimensional inspection was performed on the returned device.The reported material deformation was confirmed.The reported difficult to advance/position and difficult to remove were not confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.Na.
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