A review of the device history record indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.One opened trocar assembly was received and was visually inspected and was found to be nonconforming with a damaged tip and a slightly dull cutting edge at the tip.Penetration testing could not be performed due to the damage of the sample.A photo of the trocar assembly taped to a piece of paper is attached to the parent complaint and has been reviewed by the investigation site.The photo does not include enough detail to determine if there are any product defects present.The damage to the returned sample is consistent with damage that can occur when the blade contacts a hard surface such as the protective cap, improper handling, or contact with another instrument during surgery or set-up.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.Any non-conformances, such as a damaged tip, are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.(b)(4).
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