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.The returned sample was visually inspected and functionally tested.No defects were observed.Both irrigation and aspiration luers were intact.The sample primed and tuned with a handpiece successfully.The sample could be recognized and the service data could be retrieved from the console.Aspiration, max vacuum, and irrigation were tested at appropriate settings and passed testing.The sample passed functionality testing.The root cause of the customer's complaint could not be established since the returned sample met specifications.No contributing factors could be identified that could cause the reported complaint.After the investigation of this complaint, it has been determined that this sample met specifications.Therefore, no action will be taken at this time.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).
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