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

Model Number	LXMJ44S
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during laparoscopic sleeve gastrectomy with omentopexy and laparoscopic bilateral transversus abdominis plane (tap) block, the patient was brought to the operating room in stable condition, positioned supine and received general anesthesia/ intubated.Abdomen was prepped and draped in sterile fashion.Abdomen was entered after infiltration of local anesthesia.Gastrocolic ligament was opened on the greater curvature of the stomach with the vessel-sealing device and the lesser sac was entered.Short gastric vessels then divided cephalad along the greater curvature.Just prior to reaching the fundus and the angle of his, an area that had been sealed by the vessel sealer now spontaneously started bleeding and this was initially packed with a mini laparotomy pad and then it was addressed later during the case.There was an obvious bleeding vessel which had been previously sealed and cut which was now bleeding obviously, and this was controlled with further applications of the vessel sealing device.Eventually, the entire fundus was mobilized and the left crus of diaphragm clearly seen.Short gastric vessels then divided caudad along the stomach reaching a distant 6 cm away from the pylorus.Again, the vessel sealer failed to adequately seal the vessels in this area and once dissection was being performed, these vessels now started spontaneously bleeding and then they had to actually obtain a third device to stop this from happening.The third device was working appropriately and the procedure was completed with no further incident.
Additional Manufacturer Narrative
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.

• Brand Name: LIGASURE XP
• Common Device Name: 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: 21124116
• Report Number: 1717344-2025-00059
• Device Sequence Number: 8760532
• Product Code: GEI
• UDI-Device Identifier: 10884521830967
• UDI-Public: 10884521830967
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LXMJ44S
• Device Catalogue Number: LXMJ44S
• Device Lot Number: 42620173X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/10/2025
• Date Device Manufactured: 09/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 117 KG
• Patient Ethnicity: Hispanic
• Patient Race: White