(b)(4).Batch #: p94l1z, p94j6z, p94l6h.Device analysis: the analysis results found that one mcs20 device was returned with no damage in the external components.In addition, a plastic bag with a partially formed clip inside.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and it fed and formed the remaining 6 clips as intended.No conclusion could be reached as to what may have caused the reported incident.The reported complaint was confirmed.The batch history record was reviewed and identified an unformed clip falls out of the jaws or is ejected prior to being applied issue related to the reported incident were found.When this occurs, our quality system documents the necessary actions to ensure final product quality.The final quality release criteria were met before this batch was released for distribution (p94l1z, (p94j6z).In addition, no protocols or ncr related to the complaint, were found during the manufacturing process.Manufactured date: 12/19/2017.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process (p94l6h).Manufactured date: 12/21/2017.
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