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Model Number TRIEEA28XT |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
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 robotic laparoscopic low anterior resection, connecting the sigmoid to the rectum, the black knob turned two full 360 degrees to the left until a click was heard, then pulled the circular stapler out in a figure 8 motion (pull straight out with no tension).The anvil was stuck inside while the handpiece came out.The user had to retrieve the anvil trans-anally; there was no damage to the patient.Anastomosis was formed with two in-tact donuts.
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Search Alerts/Recalls
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