Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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According to the reporter, during a cholecystectomy procedure, when stapling the skin using the skin stapler and staples extractor, the skin staples were not firm, and the skin was not closed properly.Another skin stapler was used to resolve the issue.As a result, the operation time was prolonged, and the patient experienced increased pain.
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