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

Model Number LF5637

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

Patient Problems Anemia (1706); Pulmonary Emphysema (1832); Fatigue (1849); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Nausea (1970); Pain (1994); Pneumonia (2011); Pulmonary Edema (2020); Renal Failure (2041); Shock (2072); Urinary Tract Infection (2120); Vomiting (2144); Electrolyte Imbalance (2196); Hypovolemia (2243); Anxiety (2328); Coma (2417); Respiratory Acidosis (2482); Abdominal Distention (2601); Fluid Discharge (2686); Nodule (4551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/07/2022

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during vats procedure, the ligasure device split from the handle half way down the outside sleeve.The patient was in the icu (intensive care unit) and the procedure which was originally laparoscopic was turned into an open thoracotomy procedure to control the bleeding and remove the tumor.

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

According to the reporter, during vats procedure for thymoma resection, the ligasure device split from the handle half way down the outside sleeve with a sharp edge at the fracture site noted during removal.It was noted that there was a blood loss of 2 liters.The procedure which was originally laparoscopic was turned into an open thoracotomy procedure to control the bleeding and remove the tumor.X-ray confirmed that there were no foreign body left in the patient's body.The patient had a heart attack (myocardial infarction).Patient was admitted in the icu (intensive care unit) and was in a coma for a couple of days.Discharged from the hospital and had 2 heart attacks; within 22 hours the patient died.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all received information.The device was available for evaluation the primary analysis finding was that the unit had an outer tube/shaft failure.It was reported that the device broke during use.This complaint was confirmed based on the actual device.The product analysis of the device found that the damage to the shaft is consistent with excessive amount of force on the shaft.This defect can be traced to misuse.The most likely root cause was traced to the user.A device history review was performed.The device history review determined that there was insufficient information to conduct the specific investigation action.The event had foreseen risk and is included in a data monitoring plan.The instructions for use states: - do not bend instrument shaft.- if the instrument shaft is visibly bent, discard and replace the instrument.A bent shaft may prevent the instrument from sealing or cutting properly.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.

Manufacturer Narrative

(patient codes, imf codes, e2402: ventricular hypertrophy, reduced systolic function, dilated right atrium, ascending aorta dilation, l bundle branch blockage, abnormal ecg with wide qrs rhythm) 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.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.During vats procedure for thymoma resection, the device split from the handle half way down the outside sleeve with a sharp edge at the fracture site noted during removal.It was noted that there was a blood loss of 2 liters.The procedure which was originally laparoscopic was turned into an open thoracotomy procedure to control the bleeding, repair of cardiac injury and resection of mediastinal mass.X-ray confirmed that there were no foreign body left in the patient's body.The patient had a heart attack (myocardial infarction).The patient experienced electrolyte imbalance, abnormal ecg with wide qrs rhythm, l bundle branch blockage, left ventricular hypertrophy, reduced systolic function, severely dilated right atrium, ascending aorta dilation, fatigue, 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, coma for several days, pulmonary edema, post-operative pneumonia, continuous pain, suffering for the remainder of his life, and death.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 h ypotension, chest x-ray confirmed et tube placement, right neck catheter, 2 left-sided chest tube, ng tube placement, physical therapy, abnormal ekg.Patient was discharged from the hospital and had 2 heart attacks within 22 hours and the second one killed the patient.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 14021619
• MDR Text Key: 288666943
• Report Number: 1717344-2022-00398
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521521735
• UDI-Public: 10884521521735
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF5637
• Device Catalogue Number: LF5637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death; Life Threatening; Hospitalization
• Patient Sex: Male
• Patient Weight: 160 KG
• Patient Race: Black Or African American