Additional information provided in d.10., h.3., h.6., and h.10.One opened total plus pak with various components was received but no trocar assemblies were returned for the reported issue of the parts of the product fell to the eyeball; 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.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.An acceptance quality inspection is performed to ensure product meets release acceptance criteria.Non-conforming product is removed from the lot.The inspection includes evaluation for trocar hub/cannula assembly loose on the trocar blade.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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