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

Model Number	LF1837
Medical Device Problem Codes	Difficult to Open or Close (2921); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 near the end of a gynecological procedure, the jaws of the handpiece were not opening or closing properly, describing then as "stiff".By that point the vessel sealing portion of the procedure was finished, so he didn't need to open a new device.Another handpiece was working properly with the same generator.There was no patient injury.
Event or Problem Description
It was reported that near the end of a gynecological procedure, the jaws of the handpiece were not opening or closing properly, describing them as "stiff".By that point the vessel sealing portion of the procedure was finished, so he didn't need to open a new device.It wasn¿t during a specific time or on a particular structure.No issues with the knife blade.Another handpiece was working properly with the same generator.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3.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 knife damage.Minor eschar build-up on seal plates observed.Functional testing found that the product analysis found the device's jaw opening and closing mechanism was functioning properly.The weld integrity of the device was inspected and was found to be within specification.The device's knife blade advanced and retracted properly.The knife cut of the device was tested on a silicone test strip with mediocre results.The jaw gap of the device was measured and it was found to be within specification.The device was detected when plugged into generator 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 was activated with the rotation knob in various positions to detect any problematic activation issues.No electrical or wiring issues were found.It was reported that the jaws was difficult to open, device stopped working and the device was difficult or impossible to close.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The evaluation detected an unreported condition: of knife damaged.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.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: do not engage the cutting mechanism over clips, staples, or other metal objects as damage to the cutter may occur.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: 23512073
• Report Number: 1717344-2025-01468
• Device Sequence Number: 13230983
• Product Code: GEI
• UDI-Device Identifier: 10884521195219
• UDI-Public: (01)10884521195219(17)300721(10)52030354X(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162941
• 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): 02/04/2026

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: LF1837
• Device Catalogue Number: LF1837
• Device Lot Number: 52030354X
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 02/02/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/17/2025; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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
• Patient Sex: Unknown