Additional information is provided.No sample has been returned for evaluation for the report of blade tip is bent and not cutting tissue therefore, the condition of the product could not be verified.A review of the device history record related to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates that there is one additional complaint associated with the lot for the reported issue.A sample was not returned and the device history record review of the lot number provided indicates that the product was processed and released according to acceptance criteria therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown therefore, specific action with regards to this complaint cannot be taken.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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