MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE PTFE ELECTROSURGICAL BLADE ELECTRODE MODIFIED EXTENDED INSULATION; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	0012M
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A few minutes after the case started, the surgeon began using cautery.The surgeon, (b)(6), and tech all saw a 2 inch tall flame for a brief second and then it was gone.The flame was immediately reported to the or nurse.The bovie tip that caused the flame did not cause damage to the patient, but it was removed from the field and a new bovie tip was used for the remainder of the case.The tip was sent to clinical engineering and will be returned to the manufacturer for failure analysis.Manufacturer response: for electrosurgical, cutting coagulation accessories, megadyne (per site reporter): customer support was contacted.The device will be returned for failure analysis.Any further contact will be shared with medsun.

• Brand Name: MEGADYNE PTFE ELECTROSURGICAL BLADE ELECTRODE MODIFIED EXTENDED INSULATION
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 s. state st.; draper UT 84020
• MDR Report Key: 8124203
• Report Number: 8124203
• Device Sequence Number: 2363668
• Product Code: GEI
• UDI-Device Identifier: 10614559100110
• UDI-Public: (01)10614559100110
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2018
• Report Date (Section F): 11/26/2018

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: 0012M
• Device Lot Number: 183744
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 74
• Date Report Sent to FDA: 11/26/2018