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Model Number EGIA60AMT |
Device Problems
Break (1069); Component or Accessory Incompatibility (2897); Human-Device Interface Problem (2949)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: sigadaptshort, sig power sigadaptshort lin short adapt (serial#: (b)(6)); sigphandle, sig power sigphandle handle (serial#: unknown); sigpshell, sig power sigpshell control shell (lot#: n3j2117y).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 oesophagectomy procedure, before using on the patient, the reload would not go on the adapter properly, hence the device could not be used for firing.Visually, the black ring connection part of the reload broke, and then the reload would not come off either.To resolve the issue, another reload and adapter was used.There was no patient injury.
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Search Alerts/Recalls
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