One opened probe was received.The returned sample was visually inspected and found to be non-conforming with orange/brown foreign material on the port face and the tip of the inner cutter visible through the port of the needle.The sample was then functionally tested for actuation and cut.The sample was found to non-conforming for actuation with no movement of the inner cutter.The cut functionality of the returned probe could not be tested due to the actuation failure.The probe was disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.The inner cutter pulled out of the coupling.No presence of adhesive was observed on the inner cutter.The cutter/coupling adhesive bond fillet was visually inspected and found to be non-conforming.No wear marks were observed along the inner cutter.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 sample evaluation indicated that the probe had an actuation failure.The cut functionality of the returned probe was unable to be tested, however, the observed actuation failure would have led to the reported cut failure.The root cause for the observed actuation failure is the separation of components within the probe.It appears that at the beginning of surgical use the adhesive bond failed causing the inner cutter to detach from the coupling.An investigation has been completed and actions have been implemented to lower the frequency of probe complaints due to the detachment of the inner cutter from the coupling.The procedure has been reviewed and was found to provide adequate instructions to operators for the bonding process of the inner cutter to coupling.The inner cutter / coupling adhesive bond fillet for the returned sample was non-conforming.Probe assemblies are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.The manufacturer internal reference number is: (b)(4).
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