The lot complaint history was reviewed; this is the third complaint for the finish goods lot and third for this issue for this lot.The device history record (dhr) shows the product was released per specifications.A review of the dhr for the reported suspect product also confirms that this product has been sterilized and all sterilization cycle parameters were verified for acceptability prior to release.A sample was expected for this investigation but has not yet been received.Without a sample, visual inspection or functional evaluation was unable to be performed.The root cause of the customer's complaint could not be established as a sample has not been received.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.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.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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