Reference (b)(4).Investigation: x-initiated manufacturer's investigation.X-no sample returned.X-review dhr.Analysis and findings: distribution history: the complaint product was manufactured at csi on 1/22/2018 under work order (b)(4).Manufacturing record review: dhr-44-2709-233700 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: incoming inspection record review not applicable to this product.Service history record : service history not applicable for this product.Historical complaint review: a review of the attached 2-year complaint history showed similar reported complaint conditions.All similar reported complaints were attributed to use of incompatible, non-coopersurgical connectors.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause : root cause not applicable as the complaint condition was not confirmed.
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