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Model Number EGIA60CTAMT |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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, during a thoracoscopic lobectomy, during detachment of the tissue bronchus, the connection of the reload broke off.A new reload with intact accessories was used to resolve the issue.There was no patient injury.
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Manufacturer Narrative
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Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the reload had a full complement of staple and the proximal end of the reload adapter was broken.It was reported that the connection of the reload broke off.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur due to over flexure of the reload while attached to the instrument.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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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Search Alerts/Recalls
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