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

Model Number	LXMJ44S
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: lxmj44s, maryland xp inline sealer/divider 44cm (lot#42070038x).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 or Problem Description
It was reported that during a gastric bypass procedure using the device, the first handpiece failed to seal the vessel, prompting the surgeon to open a second handpiece, which also failed to seal the vessel.There was an energy activation and sealing issue, with no evidence of energy delivery and end tones heard, resulting in no seal.Bleeding occurred during the procedure.The surgical time was extended by almost 30 minutes due to these issues.
Event or Problem Description
It was reported that during a roux-en-y gastric bypass (rygb) surgical procedure using the device, the first handpiece failed to seal the vessel, prompting the surgeon to open a second handpiece, which also failed to seal the vessel.There was an energy activation and sealing issue, with no evidence of energy delivery and end tones heard, resulting in no seal.There were no audible or visible errors or alerts observed.After the surgery began, when the device failed to seal the vessels, the staff attempted to clean the jaws multiple times.No proper or satisfactory seals were achieved.The doctor was working on the mesentery, where the device failed and the tissue bundle appeared to be of normal thickness at the time the issue occurred.The surgery was continued using the ligasure after two unsuccessful attempts with the ligasure xp.Bleeding of 40 to 50ml occurred during the procedure.The surgical time was extended by almost 30 minutes due to these issues.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6 d10 concomitant products: vlft10gen, vlft10gen ft series energy platformx1 (serial#:(b)(6)) 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was no seal.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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 & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24686942
• Report Number: 1717344-2026-00450
• Device Sequence Number: 15963053
• Product Code: GEI
• UDI-Device Identifier: 10884521830967
• UDI-Public: (01)10884521830967(17)290724(10)42070038X
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2026

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: LXMJ44S
• Device Catalogue Number: LXMJ44S
• Device Lot Number: 42070038X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 05/29/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 03/31/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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: PLEASE SEE NOTE ON H11
• Patient Sex: Unknown