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 was received with inner blister, outer blister and cover foil showing the lot information.The sample showed no macroscopic signs of damage.The sample showed signs of surgery residues and was returned in a closed status.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The sample was visually inspected.It was noticed that after cleaning, the sample was damaged, and one blade had been broken.During the functionally test, it was noticed that the scissors are not able to open or close.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 customer complaint was 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 was 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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