The device history report for lot number 7247573 was reviewed, no related abnormalities were found.Material number (b)(4) for lot 7247573 was manufactured on oct-01-2017.This is the first instance of this failure mode with this lot number.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Additionally a photograph was provided for the purpose of aiding our quality engineer's investigation, unfortunately the other than confirming the failure mode the picture was not clear enough to evaluate the device in any definitive detail.Based on investigation results to date, root cause for manufacturing process cannot be determined due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.
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