The company service representative examined the system and replicated the reported event.To resolve the issue, the illuminator module and xenon lamp were replaced.The system was then tested and met all product specifications.The illuminator module and xenon lamp were received, and a visual assessment of the returned sample revealed no obvious nonconformity.Sample testing of the returned illuminator module and lamp was performed.The reported event was not replicated and there was no problem found with the samples.A system non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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