Additional information has been provided in sections d.4, d.9, h.3, h.4, h.6 and h.10.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 macroscopic signs of damage.The shaft was bent.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 and functionally tested.It was noticed that the shaft of the device was bent and the scissors got stuck in the closed position.It only can be open by pushing the shaft manually down.The blades of the scissors are good, they pass the cutting test.Hence that the scissors were not able to open, the malfunction of the customer was confirmed.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.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 customer¿s 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.
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