Investigation no sample returned review dhr *analysis and findings distribution history the complaint product was manufactured at csi on june 07th, 2022 under work order (b)(4).Manufacturing record review dhr cr_dhr_2030_619010362 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history did show similar reported complaint conditions.Similar issues were found also for other insorb codes related to does not perform properly.On the complaints reviewed the complaint condition could not be confirmed as the product was not returned for evaluation.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation visual evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Functional 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.Root cause no definitive root cause for this issue could be reliably determined at this time because the product was not returned for evaluation.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.Not training required for this complaint.*was the complaint confirmed? no.
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