Additional information provided in d.10, h.3, h.6 and h.10.The returned sample was visually inspected and found to be non-conforming with orange/brown foreign material on the port face and white foreign material along the needle.The probe was then functionally tested for actuation, aspiration, and cut and was found to be non-conforming for all three functional tests.The probe sample 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.Foreign material was observed to be partially covering the port and port face of the cutter.The sample was tested with a syringe and resistance was felt.A wire was inserted through the aspiration path to remove the interference.The sample was retested with a syringe and no resistance was felt.The sample was retested for aspiration and actuation with the probe driver and was able to aspirate and actuate.The initial aspiration and actuation tests failed due to interferences within the probe and once the interferences (needle/shell assembly and foreign material) were removed the probe was able to aspirate and actuate.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 confirms the probe sample had an cut and aspiration failures.The evaluation also indicated that the probe had an actuation failure.The cause of the aspiration failure is due to foreign material in the aspiration path.How and when foreign material was introduced into the aspiration path cannot be determined from this evaluation; however, the foreign material is most likely surgical material from the surgical use of the probe.The cause of the actuation and cut failures is the observed damage/wear to the inner cutter of the probe.A damaged/worn inner cutter can impede the movement of the cutter shaft, causing to probe to not be able to perform the cut.And a damaged cutting edge can decrease the quality of the cut performed by the probe.How and when the inner cutter of the probe became damaged/worn cannot be determined form this evaluation.No specific action with regard to this complaint was taken by the manufacturing site because the probe sample was able to aspirate once the observed foreign material was removed from the aspiration path and the exact root cause of the actuation and cut failures could not be determined.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.Complaints will be continued to be reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.The manufacturer internal reference number is: (b)(4).
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