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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 with tip protector in a bubble bag with a tray label was received for the report.The sample was visually inspected and found to be nonconforming with orange/brown foreign material on the welded cap and body needle bent at the stiffener.The sample was then functionally tested for actuation, aspiration and cut.The sample was found to be nonconforming for actuation, conforming for aspiration and nonconforming for cut.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 bent.Gouge marks at area that was bent on the inner cutter.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification 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 was unable to identify the root cause or origin of the reported event.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.The complaint evaluation does not confirm the reported problem; the evaluation indicates the probe had an actuation and cut 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 and cut 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.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time as the reported aspiration failure was not confirmed, and an exact root cause for the bent needle and the bent inner cutter could not be determined from this evaluation.A nonconformance investigation has been completed to investigate the trend identified for probes with would not cut or actuate issues.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.Complaint data for all company products is reviewed monthly to monitor for adverse trends.During the last review, 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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