Two opened probes were received in a tray for the report of actuation failure and abnormal noise.Per follow up details, the probe still attached to the cassette is not the complaint probe, the other probe will be evaluated as part of this investigation.The sample was visually inspected and found to be non-conforming with orange/brown foreign material on the port face and welded cap.The probe was then functionally tested for actuation, aspiration, and cut and was found to be conforming for all three functional tests.No noise was observed during functional testing.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.A complaint history examination for device component lots traceable to the reported lot number indicates there are three additional complaints associated with the component lots for the reported issue.The returned sample was found to be functionally conforming, therefore an actuation failure with abnormal noise as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the probe was functionally conforming.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-concordances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.The manufacturer internal reference number is: (b)(4).
|