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Model Number UNKNOWN EGIA TRI STAPLE |
Device Problems
Retraction Problem (1536); Firing Problem (4011)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: egiaushort, egiaushort endogia ultra univ sht stap (lot#p3d0501) unegiatri, unknown egia tri staple (lot#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 thoracoscopic pulmonary alveolus resection procedure, when using reload 1 to 2 for bra resection, the trigger was heavy when firing from the first shot, and when the knob was pulled back in order to retract the knife after bulla resection, the retraction was heavy.After that, stapler felt even heavier after the second firing using second reload, and the retraction when the knob was pulled back was also heavy.A second handle and third reload was used to resolve the issue.Also, there were no problems with the staple line in the first and second firing, and there were no abnormal points in the pulmonary tissue.There was no patient injury.
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Search Alerts/Recalls
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