(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The armada 18 is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.
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