(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for investigation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents reported for this lot.The investigation was unable to determine a conclusive cause for the reported poor visibility resulting in deployment difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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