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

Model Number	LF2019
Medical Device Problem Codes	Retraction Problem (1536); Difficult to Open or Close (2921); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a buccal mucosa cancer surgery, the device exact dissector was connected to an generator when the knife blade could not retract and the jaw could not be opened shortly after the surgery began.It was not stuck on tissue.It was used on radial vein and cleaned after each use.The knife blade protruded beyond the edge of the jaws.Another device was used successfully with the same generator.There was no patient injury.
Additional Manufacturer Narrative
D-10 concomitant product: vlft10gen ft series energy platformx1 - serial number (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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: LigaSure
• 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: 50856464
• Report Number: 1717344-2026-01282
• Device Sequence Number: 15866087
• Product Code: GEI
• UDI-Device Identifier: 10884521741096
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K173281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: LF2019
• Device Catalogue Number: LF2019
• Device Lot Number: 52470153X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 08/28/2025
• 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: SEEH11 VLFT10GEN FT SERIES ENERGY PLATFORMX1.
• Patient Sex: Unknown