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Additional information provided in d.9., h.3., h.6.And h.11.No technical inquiries were received from the customer.One opened probe was received, with a tip protector, in a pouch, for the report.The sample was visually inspected and found to be nonconforming with orange/brown foreign material on the port face.White foreign material inside the port.Needle was bent in the middle.The sample was then functionally tested for actuation and aspiration.The sample was found to be conforming for aspiration and nonconforming for actuation.The probe was disassembled and the components inspected.Nominal wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Inner cutter was observed to be bent.Gauge and wear marks observed at bend area and several other locations on the inner cutter.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 investigation conducted a non-conformance review of the reported lot number.No deviations were identified, and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information and materials received, the investigation concluded that the root cause of the reported event is not determined as the returned sample was conforming for aspiration functional testing.The complaint evaluation does not confirm the probe had an aspiration failure; the evaluation indicates the probe had an actuation failure.The aspiration function of the probe was conforming; however, the observed actuation failure could have caused the cutter to stay in the port of the needle long enough to obstruct aspiration flow at the time the reported event was observed.The most likely cause for the actuation failure is from the bent needle and bent inner cutter.A bent needle can impede the movement of the cutter shaft and aspiration flow through the probe.This interference is present as observed from visual condition of the inner cutter.The exact root cause of the bent needle and bent inner cutter cannot be determined from this evaluation.The most likely root cause is handling at any point after the probe was shipped from the manufacturing site including use during surgery.No further investigative or manufacturing actions are warranted at this time due to that the returned sample met specification for aspiration functional testing, and an exact root cause for the bent needle and the bent inner cutter could not be determined from this evaluation.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.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all company products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).
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