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

Model Number	E1450-6
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: forcefxc, forcefxc force fx generator 110v x1 (serial#(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.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 the procedure, the device¿s tip ignited (match-sized flame) during use.The flame self-extinguished after activation was stopped.No operating room fire was reported.Following the initial incident, the biomed department conducted testing on the esu and identified high-voltage issues with the generator.There was no patient harm or injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was returned with the original packaging, which was no longer sealed.Visual inspection found evidence of burning.It was reported that the device caught fire.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.Embers can appear if eschar buildup is not cleaned off the device.Eschar is flammable and should be cleaned off regularly.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: tissue build-up (eschar) on the tip of an active electrode poses a fire hazard, especially in oxygen-enriched environments, such as throat or mouth procedures.Keep the electrode clean and free of all debris.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: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana,mx
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana,mx
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23990536
• Report Number: 9610849-2026-00004
• Device Sequence Number: 18688300
• Product Code: GEI
• UDI-Device Identifier: 10884521713130
• UDI-Public: (01)10884521713130(17)300228(10)250900197R(20)01
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K955836
• 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): 03/17/2026

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: E1450-6
• Device Catalogue Number: E1450-6
• Device Lot Number: 250900197R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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: Unknown