One opened probe was received with a tip protector, in a tray along with a cassette, for the report of actuation failure.The returned sample was visually inspected and found to be conforming.The sample was then functionally tested for actuation, aspiration, and cut and was found to be conforming for all three functional tests.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 found to be conforming, therefore an actuation failure as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the returned probe was manufactured to specifications.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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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