D10 concomitant product: unknown cool-ti, unknown cool-tip rf ablation generator, (serial #unknown) reference: (b)(6), outcomes of laparoscopic radiofrequency ablation versus percutaneous radiofrequency ablation for hepatocellular carcinoma; (b)(6); surgical endoscopy (2023) 37:5176¿5189, https://doi.Org/10.1007/s00464-023-09956-1.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 was conducted between (b)(6) 2005 and (b)(6) 2020 to compare outcomes of laparoscopic radiofrequency ablation (lrfa) and percutaneous radiofrequency ablation methods (prfa) in patients with hepatocellular carcinoma.A total of 381 patients underwent prfa or lrfa using a cool-tip or a non-medtronic electrode.The following complications were reported in both rfa groups: pleural effusion, hemothorax, perihepatic bleeding and bowel injury.The author did not mention any interventions used to treat these complications.The article did not specify which electrode was associated with the reported complications.
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