No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.This report is to follow-up to medwatch report# 1501570000-2015-8007.
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(b)(4).Investigation summary: the incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections. although the root cause of the damaged shaft cannot be determined, the dent on the shaft likely happened while removing the device from the tray packaging.All clip appliers undergo 100% visual and functional inspection during the manufacturing and assembly process.As a part of this process, applied medical is currently investigating packaging enhancements intended to further minimize the potential for this type of incident to occur.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.(b)(4).
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