corrected data provide in b.5.The customer did not retain the product lot information for this procedure pack.Therefore, the device history records traceable to the reported procedure pack could not be reviewed.No sample has been returned for evaluation.Therefore, the condition of the product could not be verified.The root cause of the customer's complaint could not be established, as a sample has not been received.And the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known.Therefore, specific action with regards to this complaint cannot be taken.In-process controls are established to ensure each final assembled cassette is verified, that all required tests have been performed and all acceptance criteria are met prior to release.Quality assurance has reviewed this complaint.And will continue to monitor data for evidence of adverse trending and take further action as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).
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