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Model Number LF1937 |
Device Problems
Mechanical Problem (1384); Retraction Problem (1536); Failure to Cut (2587); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
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 lap.Colon resection, the device was plugged into a generator but it could not cut at all, knife blade could not advance and knife blade could not retract but it does not protrude beyond the edge of the jaws.Jaws were forced open and jaw had an issue.It was impossible to close and impossible to open.It was not applied to tissue at the time and it was unknown how far into the surgery this happened.Device was normally cleaned.Another ligasure was successfully used with this generator.There was no patient injury.
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Search Alerts/Recalls
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