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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number LF2019
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Radiation Exposure, Unintended (3164); No Code Available (3191)
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative
Title: feasibility of vessel sealing devices in surgical excision of vascular malformations - novel approach source: ahmed samir hosny, et al , 2020 , international journal of surgery open.(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to literature source of study performed from january 2015 to june 2018, its aim was to test the feasibility of vessel sealing devices including ligasure exact dissector and other 2 non-medtronic products in the excision of malformations, there was complication related to gangrenous skin over the patella healed by vacuum-assisted closure therapy.Post --excision mri after 18 months suggested recurrence in one patient.
 
Event Description
According to literature source of study performed from january 2015 to june 2018, its aim was to test the feasibility of vessel sealing devices including ligasure exact dissector and other 2 non-medtronic products in the excision of malformations, one patient dies three weeks later dues to post operative secondary hemorrhage.Communications initiated found out that the product was recommended by the author and didn't alleged the device as the cause of death.According to literature source of study performed from january 2015 to june 2018, its aim was to test the feasibility of vessel sealing devices including ligasure exact dissector and other 2 non-medtronic products in the excision of malformations, there was complication related to gangrenous skin over the patella healed by vacuum-assisted closure therapy.Post --excision mri after 18 months suggested recurrence in one patient.After considering the facts given in the article, it was concluded that the vacuum-assisted closure therapy and mri after 18 months were not device related outcome.Article: feasibility of vessel sealing devices in surgical excision of vascular malformations - novel approach : ahmed samir hosny, et al , 2020 , international journal of surgery open.
 
Manufacturer Narrative
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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Brand Name
LIGASURE
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
MDR Report Key10058408
MDR Text Key191113144
Report Number1717344-2020-00517
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
PMA/PMN Number
K173281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLF2019
Device Catalogue NumberLF2019
Was Device Available for Evaluation? No
Date Manufacturer Received04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age18 YR
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