MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION BOVIE; ELECTROSURGICAL GROUNDING PLATE

Model Number	A1204P
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the device used was not provided and the device will not be returned for evaluation as we were able to determine the root cause without the device.The customer was informed to purchase the a1254c and a1204p reusable grounding plate and cord for use on humans by their sales representative.This device is not recommended by bovie medical as there is a lower resistance level when using the metal grounding plate compared to the disposable pads, specifically for newer customers with no prior experience.The disposable grounding pad is designed for human use as it requires lower resistance.Whereas the metal grounding plate is designed for animal use due to a higher resistance being presented from the animal's hair.The root cause has been determined to be using the incorrect product for their intended use.The customer was issued a courtesy box of the disposable pads.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions a follow up report will be submitted.
Event or Problem Description
The patient was injured the first time the accessories were used during a leep procedure.The grounding pad caused a burn on the patient.There was no permanant damage or serious injury to the patient.

• Brand Name: BOVIE
• Common Device Name: ELECTROSURGICAL GROUNDING PLATE
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater, fl
• MDR Report Key: 9825641
• Report Number: 3007208013-2020-00005
• Device Sequence Number: 754416
• Product Code: GEI
• UDI-Device Identifier: 10607151001428
• UDI-Public: 10607151001428
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: A1204P
• Device Catalogue Number: A1204P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1