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Model Number EGIA60AMT |
Device Problems
Failure to Fire (2610); Component or Accessory Incompatibility (2897)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, during a laparoscopic surgery, after pressing the green button and squeezing the handle; the device did not fire.The reload could not be loaded.A new reload was used to resolve the issue.No patient injury.
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Manufacturer Narrative
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D10 concomitant product: sigphandle, sig power sigphandle handle ((b)(6)) 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 surgery, after pressing the green button, the device did not fire.The reload could not be loaded.A new reload was used to resolve the issue.No patient injury.
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Manufacturer Narrative
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Additional information: g3 correction: b5 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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