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

Model Number	LF5644
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure; there was inadequate or partial sealing with evidence of energy delivery and end tones heard.The devices were plugged into an ft10 generator with software version 5.0.
Additional Manufacturer Narrative
D10 concomitant product: lf5644, lig dissector lf5644 sealer div 44 cm (lot #51760188x); vlft10gen, vlft10gen ft series energy platformx1 (serial #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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted eschar buildup on the device's jaw.Functional testing found that the build up was cleaned and the device was working properly.More frequent cleaning of the jaws could have prevented build up of eschar.The device was detected and activated multiple times on a saline soaked gauze pad with satisfactory results.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.The device sealing performance was tested on porcine kidney tissue.Multiple seals on various size vessels were made and a full thermal effect was visually verified.The sealing was adequate when the seal cycle reached end tone.It was reported that there was inadequate or partial sealing.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: of eschar build up.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: keep the instrument jaws clean.Build up of eschar may reduce sealing and/or cutting effectiveness.Wipe jaw surfaces and edges with a wet gauze pad as needed.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 & 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: 22937273
• Report Number: 1717344-2025-01118
• Device Sequence Number: 9819735
• Product Code: GEI
• UDI-Device Identifier: 10884521521742
• UDI-Public: 10884521521742
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161804
• 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,Followup
• Report Date (Section B): 11/03/2025

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: LF5644
• Device Catalogue Number: LF5644
• Device Lot Number: 51700133X
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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