MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number UNKNOWN LIGASURE INSTRUMENT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Seroma (2069); No Code Available (3191)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

Title ligasure impact¿ might reduce blood loss, complications, and re-operation occurrence after abdominoplasty in massive-weight-loss pat ients: a comparative study source scandinavian journal of surgery, volume 109, 2020 (151-158) article number: 2 date of acceptance: 04 january 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed to investigate the effectiveness of the device impact in abdominoplasty compared with the conventional techniques.There were 29 patients in the ligasure group and it was reported that post-operatively 10 patients had complications including, (4) hemorrhage needing transfusion.

Event Description

Pli10: according to the literature source of study performed (b)(6) 2008 to (b)(6) 2015, the study was to investigate the effectiveness of ligasure impact in abdominoplasty compared with the conventional techniques.There were 29 patients in the ligasure group and it was reported that post-operatively had complications: (4) hemorrhage needing transfusion, (3) seroma, (2) deep wound infection, (1) wound dehiscence, and (1) fat necrosis.None of the adverse events are related to any technical problems with the device.

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.

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 10286002
• MDR Text Key: 199235523
• Report Number: 1717344-2020-00745
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LIGASURE INSTRUMENT
• Device Catalogue Number: UNKNOWN LIGASURE INSTRUMENT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR