06/05/2020 02:30 pm.Additional information provided in d.10., h.3., h.6., and h.10.One opened probe was received with a tip protector, in a tray along with other unused items, for the report of actuation failure.The returned sample was visually inspected and found non-conforming with orange/brown foreign material in the port and on the welded cap.The sample was then functionally tested for actuation, aspiration and cut.The sample was found conforming for actuation and aspiration and was non-conforming for cut.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 one other location along the inner cutter.A piece of the side of the cutting edge was observed to be missing.Orange/brown foreign material was observed on and inside of the inner cutter.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 complaint evaluation did not confirm that the probe had an actuation failure.Unrelated to the reported event, the evaluation indicated that the probe had a cut failure.The cause for the poor cutting is the observed damage to the inner cutter of the probe.A damaged inner cutter can decrease the quality of the cut performed by the probe.How and when the inner cutter of the probe became damaged cannot be determined from this evaluation.The evaluation did not confirm an actuation failure and the exact root cause of the damaged cutter cannot be determined.Therefore, no specific action with regard to this complaint was taken by the manufacturing site.All probes are 100% tested for actuation, aspiration, and cut during manufacturing.The manufacturer internal reference number is: (b)(4).
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