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Model Number EGIA60AMT |
Device Problems
Difficult to Insert (1316); Difficult to Open or Close (2921); Human-Device Interface Problem (2949)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2024 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant products: sigtrsb60amt, sigtrsb60amt 60mm med thk reinforced rel, (lot #n3f0116y) sigphandle, sig power sigphandle handle, (sn: unknown) sigpshell, sig power sigpshell control shell, (lot #unknown) sigadaptstnd, sig power sigadaptstnd linear adapter, (sn: unknown).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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, during a laparoscopic colon resection, an attempt was made to use a 60-millimeter reload for intestinal resection.However, when the jaws were closed outside the body, the jaws were not completely closed, and it was difficult to insert through the trocar.So, the jaws were inserted while closing them with the left hand.Articulation was performed for approach, and when articulation was returned, the articulated part did not straighten, so discomfort was felt.It was replaced with another 60-millimeter reload.After that, while approaching the tissue to perform a side-to-side anastomosis (fee) with a reinforced 60-millimeter reload, the sheet came off.To resolve the issue, another product was used.There was no patient injury.
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Search Alerts/Recalls
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