MAUDE Adverse Event Report: Covidien LigaSure XP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	LXMJ37S
Medical Device Problem Codes	Energy Output Problem (1431); Intermittent Energy Output (4025)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed around 5-10 ml after cutting.There was no re-grasp alert.Blood transfusion was not required.The device was used during a low anterior resection procedure on upper gi tissue/vessels with tissue thickness reported around 4-5mm, after a few good seals before it started giving problem.Jaw cleaning was done after every 3-4 time of usage.Another device was reported to have been used successfully with the same generator.
Additional Manufacturer Narrative
D10 concomitant products: lxmj37s, maryland xp inline sealer/divider 37cm (lot#:42550119x), lxmj37s, maryland xp inline sealer/divider 37cm (lot#:42550119x) 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; 6044 longbow court; boulder CO 80301 -329
• Manufacturer (Section G): Covidien; 6044 longbow court; boulder CO 80301 -329
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50423552
• Report Number: 1717344-2026-01155
• Device Sequence Number: 9634571
• Product Code: GEI
• UDI-Device Identifier: 10884521830943
• UDI-Public: (01)10884521830943(17)290910(10)42550119X
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• 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: Foreign,Health Professional,Distributor
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: LXMJ37S
• Device Catalogue Number: LXMJ37S
• Device Lot Number: 42550119X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/25/2026
• Date Device Manufactured: 09/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown