(b)(4).Date of event: unknown.Batch #: r93k1h.Device analysis: the analysis results found that an er320 device was returned inside its package unopened.The package was visually inspected and no damaged was observed.In addition, a methylene blue test was conducted and it was confirmed that the sterility was not compromised.No conclusion could be reached as to what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device lot r40m0u number, and no non-conformance's were identified.A manufacturing record evaluation was performed for the finished device batch r93k1h number, and no non-conformance's were identified.
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