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Model Number LF2019 |
Device Problems
Failure to Cut (2587); Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2024 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant products: lf2019, exact dissector lf2019 ligasure 21cm (lot#33490161x) vlft10gen, vlft10gen ft series energy platformx1 (sn: (b)(6)) vlft10gen, vlft10gen ft series energy platformx1 (sn: (b)(6)).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, surgeon the sensed that the tissue sticks to the jaws and the knife did not cut as well.Another ligasure device used successfully.There was no patient injury.
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Manufacturer Narrative
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Additional information: d9 (return date).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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