The customer returned two curved scissor samples to manufacturing for evaluation.One sample was received with the original outer blister and cover foil.The other sample was in the original package, unopened.The opened sample was visually inspected with the aid of a photomicroscope and with various magnifications.It was found that the scissors is bent and one blade is broken off.In fact, it is unclear whether the sample condition is the same that the customer originally complained because the instrument was not protected during shipping and laid loosely in the blister.The other sample was tested and meets specification.The complaint history was reviewed two years back.It showed one comparable complaint with a bent scissor blade.It cannot exactly be determined how or when the damage occurred however, the damage to the complained sample is consistent with damage that can occur due to external force and or due to transport.No injuries have been reported or are expected related to this issue.A manufacturing or design related root cause for the damage of the complained device has not been identified.Possible root causes related to external impact which leads to this kind of damage could not be determined.The manufacturer has no influence on complaints which are in relation to external force.No further actions will be issued.(b)(4).
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