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.System message 3440, "no more irrigation fluid available.Press to change the fluid container," was reported with balanced salt solution remaining in the bottle.The presentation of a system message alone does not indicate that a malfunction has occurred.System messages and associated actions are intended functions presented as a precursor to mitigate an unanticipated condition.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 lot is verified that all required inspections 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).
|