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Model Number SIGTRS60AXT |
Device Problems
Misfire (2532); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2011 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the device was partially fired.It was reported that after firing, the reinforcement material did not release from the device as expected.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: failure to completely fire the reload will result in an incomplete cut or incomplete staple formation, which may result in poor hemostasis or leakage.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, while performing a pancreatic resection in pancreatic dissection case, the anchoring suture could not be detached after cutting the pancreas, and the sheet was manually cut off.No patient injury.Medtronic's initial evaluation of the incident is that an analysis of the system logs noted that the device was found to be partially fired.
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Search Alerts/Recalls
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