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Model Number 133650 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: 133650 premium surgiclip iii 9.0 (lot#: p3h1104); 133650 premium surgiclip iii 9.0 (lot#: p3h1104); 133650 premium surgiclip iii 9.0 (lot#: p3h1104).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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Event Description
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According to the reporter, intraoperatively, coronary artery bypass grafting (cabg), tried to close and it would not close; after squeezing, the clip did not fire.A new device was used to resolve the issue.There was no patient injury.
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Search Alerts/Recalls
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