A sample was not received at the manufacturing site for evaluation for the report of cannula part did not come off from the blade; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site and the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria, therefore, the root cause for the customer complaint issue cannot be determined.No action was taken as the trocar was manufactured to specifications.All trocar assemblies are 100% inspected for gage size.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.The manufacturer internal reference number is: (b)(4).
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