No sample has been returned for evaluation for the report of piece of trocar fell off; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number 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 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.An acceptance quality limit (aql) sampling is performed to ensure that the product meets release acceptance criteria.The inspection includes evaluation for damage to the trocar.Any nonconformances found are removed from the lot and scrapped.No additional action is required at this time.(b)(4).
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