Udi: (b)(4).The perforator was returned for evaluation.Device history record (dhr) - the lot number for this complaint is unknown and was not reported by the customer, and it is not visible on the returned unit.Therefore, a dhr review is not possible.Failure analysis - the perforator units were inspected using the unaided eye.Both units had visible tool markings and worn "eo" labels that could not be read.Unit 1 had a bad weld and could not hold the sleeve, the bad weld is believed to not be a manufacturing error."ifu" testing was performed.One unit had to be re-sleeved prior to testing, the other unit was tested as is.Once the re-sleeved unit was re-sleeved, it tested as intended.The second unit performed as intended.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The units were found to perform as intended and fulfilled the acceptance criteria.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.
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