A review of the device history record indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.No sample was returned and the device history record review of the lot number provided indicated product was released according to product¿s acceptance criteria, therefore, the root cause for the defect experienced by the customer cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.Any nonconformance's are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.(b)(4).
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