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Model Number 174006 |
Device Problems
Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/21/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, during a inguinal herniorrhaphy procedure, after second firing, the tacker started to lock.As a result, the surgical time was extended due to device issue.Another tacker was used to resolve the issue.
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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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Search Alerts/Recalls
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