One opened probe was received, without a tip protector, in a bag with other items.The sample was visually inspected and found to be nonconforming with orange/brownish foreign material on the port face.The sample was then functionally tested for actuation, aspiration and cut.The sample was found to be conforming for cut, and nonconforming for actuation and aspiration; however, no noise was observed.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.Gouge marks observed at several locations along the inner cutter.The sample was tested with syringe and no resistance was felt.The sample was retested for actuation and aspiration with the probe driver and was able to actuate and aspirate.The initial actuation and aspiration tests failed due to an interference within the probe and once the interference (needle assembly) was removed the probe was able to actuate and aspirate.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 complaint evaluation does not confirm the probe had a cut failure and an strange sound.The evaluation indicates the probe had actuation and aspiration failures.The cut functionality of the probe was conforming, however, the observed actuation failure could have caused the probe to not cut at the time the reported event was observed.The exact cause of the actuation and aspiration failures cannot be determined from the evaluation performed.The reported cut failure and strange sound was not confirmed, and the exact root cause of the actuation and aspiration failures could not be determined from this evaluation; therefore, no specific action with regard to this complaint was taken by the manufacturing site.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 are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
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