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

Model Number LXMJ44S

Device Problems Device Alarm System (1012); Energy Output Problem (1431)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unintended Radiation Exposure (4565)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

D10: concomitant product: vlft10gen - vlft10gen ft series energy platformx1, serial#: (b)(6).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.

Event Description

According to the reporter, post laparoscopic sleeve, the device caused post-op bleeding of more than 500cc due to drop in the hemoglobin from 14 to 9, and then down to 7.The patient was admitted to the intensive care unit for 2 days and a computed tomography scan was performed.Blood transfusions were also given.The ct scan showed a large hematoma present on the proximal portion of the stomach where the omentum is sutured the stomach.The surgeon noted that the bleeding was not from the staple line.Patient was stabilized and did not need another surgical procedure to control the bleeding.The patient had serious injury.

Manufacturer Narrative

(removed rfr alarm activation and its fdd) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, post laparoscopic sleeve, the device had activation tone / or energy delivery and end tone heard but there is no re-grasp alrert or error occured, patient become unstable around 11:00pm midnight, which was 8 huors after surgery.Device had caused post-op bleeding of more than 500cc due to drop in the hemoglobin from 14 to 9, and then down to 7.The patient was admitted to the intensive care unit for 2 days and a computed tomography scan was performed.Blood transfusions were also given.The ct scan showed a large hematoma present on the proximal portion of the stomach where the omentum is sutured the stomach.The surgeon noted that the bleeding was not from the staple line.Patient was stabilized and did not need another surgical procedure to control the bleeding.Patient had recovered and didn't returned to operating room.

Event Description

According to the reporter, post laparoscopic sleeve, the device had activation tone / or energy delivery, re-grasp alrert , and end tone heard.Patient become unstable around 11:00pm midnight, which was 8 huors after surgery.Device had caused post-op bleeding ofmore than 500cc due to drop in the hemoglobin from 14 to 9, and then down to 7.The patient was admitted to the intensive care unit for 2 days and a computed tomography scan was performed.Blood transfusions were also given.The ct scan showed a large hematoma present on the proximal portion of the stomach where the omentum is sutured the stomach.The surgeon noted that the bleeding was not from the staple line.Patient was stabilized and did not need another surgical procedure to control the bleeding.Patient had recovered and didn't returned to operating room.

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: LIGASURE XP
• 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 ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18508874
• MDR Text Key: 332870704
• Report Number: 1717344-2024-00116
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521830967
• UDI-Public: 10884521830967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2024

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: LXMJ44S
• Device Catalogue Number: LXMJ44S
• Device Lot Number: 30880294X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 02/12/2024; 03/11/2024
• Supplement Dates FDA Received: 03/05/2024; 03/26/2024
• Date Device Manufactured: 03/28/2023
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female