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Model Number EGIAUXL |
Device Problems
Failure to Fire (2610); Component or Accessory Incompatibility (2897)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2024 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: egia60amt - egia60amt egia 60 artic med thick sulu, lot# p2l0208 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, in a gastroplasty, after the stomach was completely dissected, there was a problem loading the stapler.The moment they loaded the stapler, when positioning and closing the reload onto the handle, the stapler clicked and then locked.The surgeon tried to activate the device, but it was not successful.The device was not able to fire.Another device was used to complete the case.There was no patient injury.
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Search Alerts/Recalls
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