Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.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.
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Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering noted there was debris on the distal end of the device.Engineering actuated the device, the first two clips short fed and dry fired; however, the remaining clips loaded and closed properly.The unit was disassembled; engineering found additional debris within the shaft, which indicated higher friction between the internal components.The root cause of the improper clip loading was due to debris which caused excessive friction within the shaft.All clip appliers undergo 100% visual and functional inspection during the manufacturing and assembly process.As a part of this process, each unit is inspected for clip feeding and closure during manufacturing prior to packaging.This document represents our final report.
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