Investigation x-review dhr x-inspect returned samples analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 09/21/2018 under wo #(b)(4) and shipped on 10/03/2018.Manufacturing record review: a review of the device history record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.Should the device history record be located going forward this complaint will be amended accordingly.Dhrs 248323 & 246376 were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log (b)(4).Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause: the product tested to specification as the device was found to meet all visual and functional test specifications.No root cause applicable.Correction and/or corrective action the unit was tested to specifications and returned to the customer.No further corrective action is necessary, as the complaint condition was not confirmed.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
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