The sample is received with inner blister, outer blister and cover foil showing the lot information.The sample shows macroscopic signs of damage.The sample shows signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope with various magnifications.During the visually inspection, it was noticed that one blade of the scissors are 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 malfunction was confirmed.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 root cause cannot be identified conclusively because the sample has pass the 100% inspection.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.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.The manufacturer internal reference number is: (b)(4).
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