Model Number LF1937 |
Device Problems
Entrapment of Device (1212); Failure to Cut (2587)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/26/2024 |
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 laparoscopic-assisted high anterior resection, the surgeon stated that the blade was not cutting the tissue effectively after sealing/coagulation cycle completed.The tissue got caught in the jaws rather than being cleanly cut.
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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 laparoscopic-assisted high anterior resection, the surgeon stated that the blade was not cutting the tissue effectively after sealing/ coagulation cycle completed.The tissue got caught in the jaws rather than being cleanly cut.Procedure completed with a new ligasure device that worked correctly.There was no patient injury.
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Search Alerts/Recalls
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