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Model Number EEA31 |
Device Problems
Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/20/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, during a laparoscopic resection, the anvil and the stapler cannot be connected when used for the side-to-side anastomosis, of the colon.The anvil center rod and center shaft cannot be docked.There was no click sound and the center shafts detached but it did not fell into patient cavity.The anvil of the new circular stapler was replaced with a new one, and anastomosis was completed without any problems.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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Search Alerts/Recalls
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