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

Model Number	LXMJ44L
Medical Device Problem Codes	Energy Output Problem (1431); Intermittent Energy Output (4025)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic sleeve gastrectomy, the device latch sealer/divider 44 cm was used to seal average-thickness momentum and short gastric vessels during mobilization of the stomach.Within the first 10 seals, after approximately 5 successful seals and with no jaw cleaning required, an inadequate/partial device seal occurred despite evidence of energy delivery and audible end tones.There were no errors or alerts.Bleeding of 100ml with the device seal, occurred after cutting.The device was connected to an generator, and another device was used successfully with the same generator.Surgical time was extended by 45 minutes.Blood transfusion was not required.
Additional Manufacturer Narrative
D10 concomitant products: vlft10gen ft series energy platformx1 (s/n:unknown).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: 50727336
• Report Number: 1717344-2026-01238
• Device Sequence Number: 10575062
• Product Code: GEI
• UDI-Device Identifier: 10884521830950
• UDI-Public: (01)10884521830950(17)281018(10)32930151X
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: LXMJ44L
• Device Catalogue Number: LXMJ44L
• Device Lot Number: 32930151X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2023
• 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