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

Model Number	LF1937
Medical Device Problem Codes	Device Alarm System (1012); Adverse Event Without Identified Device or Use Problem (2993); Intermittent Energy Output (4025)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a laparoscopic procedure, the ligasure maryland 37 cm device initially functioned as intended but failed to complete the seal cycle after approximately 10 to 15 successful seals of 20 millimeter omentum and vessels.The device displayed the message, ¿end point not reached, seal cycle interrupted¿.The device jaws were cleaned, and the device was disconnected from and reconnected to the generator; however, the device continued to fail to complete the seal cycle.The procedure was subsequently converted to open splenectomy, pancreatectomy, bowel surgery and stoma creation.A ligasure impact device then completed approximately one to two seal cycles of 20 millimeter vascular and connective tissue around the spleen before a similar issue occurred, with the error message ¿end point not reached, seal cycle interrupted¿ displayed.  a second ligasure impact device was opened as a replacement and functioned as intended, allowing the procedure to proceed.
Additional Manufacturer Narrative
D10 concomitant product : lf4418, open sealer lf4418 curved large jaw (lot no: 534401 ) forcetriad, forcetriad force triad energy platform (serial no: 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
• 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: 50859343
• Report Number: 1717344-2026-01285
• Device Sequence Number: 9497876
• Product Code: GEI
• UDI-Device Identifier: 10884521705913
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K170869
• 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
• Remedial Action: Repair
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LF1937
• Device Catalogue Number: LF1937
• Device Lot Number: 51830053X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female