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Model Number 8886848813 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, during a procedure, the clip fell off after clamping the tissue and was able to take it out in time.There was no patient injury.
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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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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 gynecological procedure, the clip fell off after clamping the tissue and was able to take it out in time.To resolve the issue, another device was used.There was no patient injury.
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Search Alerts/Recalls
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