Additional information provided in d.10., h.3., h.6., and h.10.One opened probe was received with a tip protector, in a bubble bag, for the report of did not actuate during surgery.The returned sample was visually inspected and found to be non-conforming with the inner cutter in the port of the needle and orange/brown foreign material on the port face.The sample was then functionally tested for actuation, aspiration, and cut.The sample was found to be non-conforming for actuation and aspiration with the inner cutter remaining in the port of the needle during testing.The cut functionality of the returned probe was unable to be tested due to the observed actuation failure.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.The inner cutter pulled out of the coupling.Presence of adhesive was observed on the inner cutter.The inner cutter/coupling adhesive bond fillet was visually inspected and found to be conforming.The inner cutter was observed to be bent.Wear marks were observed at one location 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 returned complaint sample confirmed that the returned probe had an actuation failure.Unrelated to the reported event, the evaluation also indicated that the probe had an aspiration failure.The cause of the aspiration failure was the inner cutter remaining in the port of the probe needle due to the actuation failure and, therefore, obstructing aspiration flow through the probe.The root cause for the observed actuation failure is the separation of components within the probe.It appears that during surgical use the adhesive bond failed causing the inner cutter to detach from the coupling.An internal investigation was completed and additional controls within the manufacturing process have been implemented to reduce the frequency of probe complaints for detachments of the inner cutter from the coupling.The procedure was reviewed and found to provide adequate instructions to operators for the bonding process of the inner cutter to coupling.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed for this reported event.The manufacturer internal reference number is: (b)(4).
|