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

Model Number UNKNOWN LIGASUR

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Pulmonary Emphysema (1832); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Pneumonia (2011); Pulmonary Edema (2020); Shock (2072); Urinary Tract Infection (2120); Anxiety (2328); Respiratory Acidosis (2482); Abdominal Distention (2601); Fluid Discharge (2686); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a video assisted t horacoscopic surgery.During use, the procedure was converted to an open left thoracotomy, repair of cardiac injury and resection of mediastinal mass when the device suddenly broke, cracked, fractured and/or otherwise failed inside the patient's chest causing an avulsion injury to the patients left anterior descending artery.The patient experienced hypotension, hypovolemia, shock, ligation of lad branch, respiratory acidosis, prerenal hyperkalemia, acute kidney injury, normocytic anemia, leukocytosis, abdominal distention, nausea, anxiety, emesis, serosanguinous output from chest tube, uti, severe hypokinesis, multiple air filled distended small bowel loops, emphysema, mass, pulmonary edema, post-operative pnuemonia, as well as experiencing bleeding, damage, continuous pain and suffering for the rest of his life.Post-operative treatments included transfer to pacu, intubated with icu admission, arterial and central line placements, sedation with fentanyl + propofol, iv fluids for hypovolemia, mechanical ventilation, electrolyte correction and repletion, norepinephrine infusion for ongoing hypotension, chest x-ray confirmed et tube placement, right neck catheter, 2 left-sided chest tube, ng tube placement, physical therapy, abnormal ekg, information received indicates the patient is now deceased due to cardiac arrest.

Manufacturer Narrative

Additional information: this event has been found to be a duplicate of a previously reported event: documented under regulatory report# 1717344-2023-00108.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.

Event Description

Duplicate of pe (b)(4).

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16218895
• MDR Text Key: 307838401
• Report Number: 1717344-2023-00093
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LIGASUR
• Device Catalogue Number: UNKNOWN LIGASUR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Death; Hospitalization
• Patient Sex: Male
• Patient Weight: 160 KG
• Patient Race: Black Or African American