The lot specific to this event is not known; therefore, lot history and device history record reviews are not possible.A sample has not been returned for this complaint; therefore, the condition of the product could not be confirmed.The root cause of the customer's complaint is not known; a sample was not returned for investigation.Potential root causes include product components, an error made during the assembly process, and customer handling, including facility cleaning.Action will not be taken for this occurrence as the root cause is not known.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.(b)(4).
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