Dhr review disclosed no indication of the alleged defect as there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product for the defect stated in the pir.Set-up and in process samples (including but not limited to) for damaged component (grip, button, spring, hub), needle retraction by button activation and adhesive overfilled/drip as well as periodic cleaning/alignment of the glue grippers were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Observations and testing could not be performed because units were not received for investigation of this incident.Confirmation of the defect stated in the pr could not be identified or confirmed and cause could not be determined, as the unit described in the product incident report was not returned for evaluation and testing.Therefore, there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the defects stated in the pir.This incident is indeterminate.
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