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

Model Number	LF4418
Medical Device Problem Codes	Energy Output Problem (1431); Failure to Cut (2587); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: lf4418, open sealer lf4418 curved large jaw (lot#52060094x) 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 procedure involving the use of three devices, the devices did not cut and no seal was achieved.There was no evidence of energy delivery, and no end tones were heard.The devices were plugged into a generator at the time of the event, and another device was used successfully with the same generator.There was no patient injury.
Additional Manufacturer Narrative
Additional information: a1, b5, g3, h6 additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.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 prior to use, three devices could not cut at all and there was no seal, with no evidence of energy delivery and end tones heard.The devices were plugged into a generator at the time of the event, and another device was used successfully with the same generator.There was no patient involvement.

• Brand Name: LIGASURE IMPACT
• 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: 24608190
• Report Number: 1717344-2026-00389
• Device Sequence Number: 10224942
• Product Code: GEI
• UDI-Device Identifier: 10884521612525
• UDI-Public: (01)10884521612525(17)300724(10)52060094X
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K162047
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: LF4418
• Device Catalogue Number: LF4418
• Device Lot Number: 52060094X
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 07/25/2025
• 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: PLEASE SEE NOTE ON H11
• Patient Sex: Female