The customer returned a sample of disposable curved scissors.The sample was received without the inner blister, but was inside of the outer blister and not protected during transport.The sample was visually inspected with the aid of a photomicroscope and with various magnifications.It was found that the scissors are 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 complaint history was reviewed two years back.It showed two comparable complaints with 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.The manufacturer internal reference number is: (b)(4).
|