Corrections: this complaint was previously filed under 1320894-2019-00030 as the manufacturer.It has since been determined that transmed is the responsible party, we are the importer.(b)(4).Distributor narrative; the manufacturer, transmed (b)(4) co.Ltd, is responsible for performing evaluation, investigation and any remedial actions related to this reported device issue per agreement with (b)(4) corporation.This issue will continue to be monitored through the complaint system to assure patient safety.
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This is a voluntary distributor report: the (b)(4) representative reported that during an endoscopic mucosal resection (emr) the doctor placed 5 clips on the antral bulb defect using the dco235w, 16mm duraclip applier.There were no reported issues with the initial surgery; however, the patient returned a few days later with bleeding because a few of the clips fell off.The patient was hospitalized.Further attempts were made to find out what intervention were done; however, no other information was received other than the patient's status is good.This report is being raised based on patient injury.
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