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.One opened probe was received with a tip protector, in a plastic bag, for the report of body separated.The returned sample was visually inspected and found to be non-conforming with the shell separated from the probe housing and red/orange foreign material along the probe needle and on the port face.The probe 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.Wear marks and gouge marks were observed at one location along the inner cutter.Red/brown foreign material was observed on the tip of the inner cutter and on the inner cutter and coupling.Photos of the pak label and product are attached to the parent file and have been reviewed by the manufacturing site.The product and lot information seen on the pak label matches what was reported.The product photo confirms that the probe shell was detached from the probe engine assembly.The complaint evaluation confirms that the probe shell was detached.The exact cause of the detached shell cannot be determined from this evaluation.A wear evaluation of the inner cutter indicated that the probe was used for a time greater than that seen during the manufacturing testing of the reported product.Therefore, the most likely root cause is handling at any point after the probe was shipped from the manufacturing site.An exact root cause for the detached shell was not determined from this evaluation, therefore, no specific action with regard to this complaint was taken.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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