MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE; ELECTROSURGICAL, CUTTING, COAGULATION & ACCESSORIES

Model Number	0035H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Plugged in bovie and it activated on its own.Unplugged it, and made sure button was not being depressed and plugged it back in.It activated again but the staff took the bovie off the field and replaced with another.

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL, CUTTING, COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 6986482
• Report Number: 6986482
• Device Sequence Number: 1471856
• Product Code: GEI
• UDI-Device Identifier: 10614559100493
• UDI-Public: (01)10614559100493(17)220531(10)1606094
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2017
• Report Date (Section F): 10/24/2017

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: Nurse
• Device Expiration Date: 05/31/2022
• Device Model Number: 0035H
• Device Catalogue Number: 0035H
• Device Lot Number: 1606094
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2017
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Date Report Sent to FDA: 10/24/2017