One opened probe was received, with a tip protector, in a bubble bag.The sample was visually inspected and found to be nonconforming with orange/brownish foreign material on the port face and in the port.The sample was then functionally tested for actuation, aspiration and cut.The sample was found to be conforming for all functional tests.No vibration observed a review of the device history record traceable to the lot number obtained from the device¿s radio-frequency identification (rfid) tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned sample was found to be functionally conforming, therefore vibration, actuation and aspiration failures as described in the complaint were 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 functionally conforming.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required the manufacturer internal reference number is: (b)(4).
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