Additional information provide in d.9., h.3., h.6., and h.10.One opened probe was received.The returned sample was visually inspected and found to be non-conforming with white foreign material in the port.The sample was then functionally tested for actuation and cut and was found to be conforming for both functional tests.A photo of the product is attached to the parent file and has been reviewed by the manufacturing site.The functionality of the probe cannot be determined from the photo.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 sample was found to be functionally conforming, therefore a cut failure 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 returned probe was functionally conforming.All 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.The manufacturer internal reference number is: (b)(4).
|