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Model Number TRIEEA28MT |
Device Problems
Misfire (2532); Failure to Form Staple (2579); Noise, Audible (3273)
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Patient Problem
Failure to Anastomose (1028)
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Event Date 03/04/2024 |
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 colectomy procedure, in the anastomosis, the surgeon fully squeezed the handle but did not hear the crunch sound.The device cut the tissue, and the staples were placed but not crimped; there was poor formation.The staple line was incomplete, as was the donut.To resolve the issue, the surgeon had to pull out the staples, resected and re-stapled using a new device.
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Manufacturer Narrative
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Additional information: b5, d4(expiration date), g3, h4 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 colectomy procedure, in the anastomosis, the surgeon fully squeezed the handle but did not hear the crunch sound.The device cut the tissue, and the staples were placed but not crimped; the staples did not form.The staple line was incomplete, as was the donut.The anvil was tilted upon removal.To resolve the issue, the surgeon had to pull out the staples, resected and re-stapled using a new device.It was noted that the surgical time was extended for more than 30 minutes.
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Search Alerts/Recalls
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