The returned sample was visually inspected and found to be non-conforming with the probe needle completely broken off at the stiffener sleeve.Functional testing, wear evaluation, and disassembly activities could not be performed due to the physical condition of the probe.No lot number was identified with this complaint; therefore, lot record reviews could not be conducted.The complaint evaluation was unable to verify the reported actuation failure due to the needle of the probe being broken.The complaint details state that ¿the tip of the involved probe was broken intentionally as a mark after replacing the probe by the doctor who confirmed that it did not actuate.¿ therefore, the complaint could not be confirmed and a root cause was unable to be determined.The complaint could not be verified and a root cause could not be determined; 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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