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Model Number GIA80MTC |
Device Problems
Break (1069); Failure to Fire (2610); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, during an open colon resection procedure, during the dissection of the small intestine, the surgeon tried to push the black thumb pusher with no effect at all, and the device did not fire.The device made a noise, and it did not work.It was noted that the blue part on the cartridge was broken.A new cartridge was loaded into the same handle to resolve the issue.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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