Additional information provided in d.10., h.3., h.6., and h.10.One opened probe was received with a tip protector, along with the tip of the probe needle wrapped in gauze, in a bubble bag, for the report of broken tip.The returned sample was visually inspected and found non-conforming with the probe needle broken at the port and orange/brown foreign material on the remaining face of the port.The probe was disassembled and the components inspected.Nominal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks were observed at the cutting edge and several other locations along the inner cutter.No lot number was identified with this complaint; however, a review of the device history records traceable to the lot number obtained from the customer returned device¿s radio frequency identification device (rfid) tag indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation confirmed that the probe had a broken tip at the port.The exact root cause for the broken tip cannot be determined from this evaluation.An internal investigation has been completed to further evaluate the cause of probe tip breakage at the port.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will continue to be reviewed and closely 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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