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

Model Number	E1450-4
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The provider was using a covidien blade electrode 4" bovie during a case, and during the use of the bovie, the tip caught fire, with a small flame appearing.The provider noticed immediately, and waved the bovie in the air and the flame was quickly extinguished.The bovie was unplugged and put to the side, and another plugged in and used without issue for the remainder of the case.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 25769438
• Report Number: 25769438
• Device Sequence Number: 10498218
• Product Code: GEI
• UDI-Device Identifier: 10884521713123
• UDI-Public: (01)10884521713123
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026
• Report Date (Section F): 07/09/2026

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: E1450-4
• Device Catalogue Number: E1450-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/09/2026