Title: laparoscopic and open liver resection for hepatocellular carcinoma with type 2 diabetes mellitus: multicenter propensity score-matched study source: hepatology international (2023) 17:1251¿1264 | published online: 15 april 2023 d10 concomitant product: unknown ligasur, unknown ligasure instrument (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.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 study compared outcomes of hepatocellular carcinoma patients with type 2 diabetes mellitus treated with laparoscopic versus open liver resection between (b)(6) 2014 and (b)(6) 2017.In the laparoscopic group, ligasure or a competitor device were used to transect the liver parenchyma.There were a total of 230 patients in the study with 101 in the laparoscopic group and 129 in the open group.Complications in the laparoscopic group included biliary fistula and abdominal infection.Interventions were not reported.
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