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Additional information provided in d.9., h.3., h.6.And h.11.Three opened probes with tip protectors in a zip top bag were received.Sample 1 was visually inspected and found to be nonconforming with orange/brown foreign material on the port face, inside the port and on the welded cap and body needle severely bent at stiffener.No functional testing could be performed due to the severely bent needle.No wear assessment could be performed due to the inner cutter broke while trying to extract it from the severely bent needle.Sample 2 was visually inspected and found to be nonconforming with orange/brown foreign material on the port face, inside the port and on the welded cap.The sample was then functionally tested for actuation and cut.The sample was found to be conforming for both tests.The probe engine was disassembled, and the components inspected.The diaphragm, spacer, top o-ring are all intact.Bottom o-ring has inner diameter damage.Sample 3 was visually inspected and found to be nonconforming with orange/brown foreign material on the port face, inside the port and on the welded cap.The sample was then functionally tested for actuation and aspiration.The sample was found to be conforming for both functional tests.The probe engine was disassembled, and the components inspected.The diaphragm, spacer, top o-ring are all intact.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 was unable to confirm the reported cut failure due to probe needle bent condition.How and when the probe needle became bent 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.Sample 2: the root cause of the reported event is not determined as the returned sample was conforming for all functional testing.However, a manufacturing related potential contributor factor was identified, damaged was observed on the o-ring and cannot be ruled out for the actuation problem as reported.Sample 3: the root cause of the reported event is not determined as the returned sample was conforming for functional testing.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time as an exact root cause for the bent needle of sample 1 could not be determined from this evaluation, sample 2 and sample 3 were functionally conforming.However, a non-conformance was completed for the damage observed on the o-ring of sample 2.A nonconformance investigation was 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.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 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
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