(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The reported difficulties were confirmed.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 identified no similar incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported difficulties.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.
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