D10 concomitant product: unknown egia su, unknown endo gia sulu, (lot #unknown).Author: matteo uccelli, md / stefano olmi, md title: laparoscopic surgery of gastric cancer with d2 lymphadenectomy and omentum preservation: our 10 years experience source: journal of laparoendoscopic; advanced surgical techniques volume 30, number 7, 2020 | 10.1089/lap.2019.0781.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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According to the literature, a retrospective study analyzed outcomes of patients who underwent laparoscopic treatment for gastric cancer with d2 lymphadenectomy and omentum preservation between january 2010 and 2018.It was noted that a ligasure maryland or competitor product was used to aid in dissection and vessel ligation.There were 138 patients included in the study and complications included anastomotic leakage and bleeding, which were treated with conversion to open, re-operation and transfusion.
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