COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
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Model Number UNKNOWN COOL TIP ELECRTRODE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Pleural Effusion (2010); Ascites (2596); Syncope/Fainting (4411); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Title: suppression of local tumor progression in perivascular hepatocellular carcinoma by combination therapy with radiofrequency ablation and percutaneous ethanol injection: a propensity score matching analysis source: oncology 2022;100:303¿312 doi: 10.1159/000522374.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.
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Event Description
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According to the literature, a retrospective study of 167 patients from 2001 to 2015 compared the safety and efficacy of radiofrequency ablation (rfa) plus percutaneous ethanol injection (pei) for rfa monotherapy in early hepatocellular carcinoma (hcc) located near peritumoral vessels.All other reported complications were minor, non serious injuries including fever, pleural effusion, ascites, biloma, portal vein thrombosis and vagal reflex.
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Search Alerts/Recalls
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