A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A design change was initiated to improve the reliability of the device.The sample received with inner blister, outer blister and cover foil showing the lot information.The sample shows no macroscopic signs of damage.The sample shows no signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The sample was functionally tested.It was noticed that the aspiration was not working properly.As the blister was opened by the customer, he handled the product.The point in time when the malfunction occurred, can no longer be determent.The customers complaint is confirmed it cannot be determined how or where the damage to the sample occurred; therefore a root cause for the customers reported event could not be determined.The exact root cause for the customers reported event is unknown, therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.The manufacturer internal reference number is: (b)(4).
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