The (b)(4) unopened pcs of skin staplers were returned for investigation.Visual inspection indicated no damage, breakage or dirt.There was no indication of external impact on the returned samples.The staples inside the cartridges were loaded correctly.Components were disassembled and there was no damage, breakage or dirt found.There were no problems found with the components and measurement values of the components from the returned staplers.Use testing performed on samples indicated proper function.The staples released without problems and the stapling function performed properly.Production records for batch number u158025700 were reviewed and there was no problem found in the production record or with the returned samples, disassembled components or measurement values of the components including staples by disassembled component check or reproducibility test.The complaint can not be confirmed or reproduced.No action is required.
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