The device was not returned for evaluation, so unable to investigate for root cause.The review of the device history records (dhr) for assembly of the finished se5425wb lot w8735 showed the product was properly manufactured, tested, and met all specifications at the time of release.The review of the device history records for the manufacture of the light pipe (part # 102032812) showed that for each of the six lots manufactured and used in lot w8735 (light pipe lots m0034-152, -203, -204, -345, -462, and -463) that the record were acceptable, all functional testing and visual inspection was performed per procedure, no negative quality patterns were reviewed and no non-conformances are associated with the device history records.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.(report 4 of 4 0001920664-2021-00108) see related reports 0001920664-2021-00105, 0001920664-2021-00106, 0001920664-2021-00107.
|