The investigation is completed.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.The sample received with outer blister and cover foil, but without inner blister.The sample shows macroscopic signs of damage.One blade of the scissors is broken.The sample shows signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The sample was visually inspected.It was noticed that one blade of the scissors is broken.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.However, the damage was consistent with damage that can occur due to improper handling.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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