Additional information is provided.The customer reported that the light went out during the procedure with the system.After few minutes, the light came on again and the surgery was completed.There was no patient harm.The company service representative examined the system and was able to replicate the reported event.The illuminator module was replaced to resolve the issue.The system was then tested and met all product specifications.The system was manufactured on november 26, 2013.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed a nonconforming illuminator module.The manufacturer internal reference number is: (b)(4).
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