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Model Number LF1837 |
Device Problem
Energy Output Problem (1431)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: blunt tip sealer divider lf1837 (lot#: 23210236x); blunt tip sealer divider lf1837 (lot#: 23210236x).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 procedure, the device was plugged into a generator, the tip cut but it did not seal.Activation and end tone was heard but sealing was inadequate/partial.Surgeon decided to change the device, but still the same.So, another device was provided again, but still the same.Surgeon decided to change device brand.Another ligasure device used successfully with this generator.There was no patient injury.
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Manufacturer Narrative
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Changed aware date to 09-jul-23 instead of 30-jun-23.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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