MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; DESSICATOR

Model Number	A942
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	01/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was using the generator at the highest setting without a grounding pad (40 watts).The customer used a non-insulated forcep when moving the skin away from the patient and received a burn from the forceps while the generator was activated.Based on this information, it can be determined that the energy from the generator was transfered from the patient to the forceps and then to the nurse due to the customer not using a grounding pad or insulated forceps.According to the generator ifu: "to avoid the possibility of electrosurgical burn to either the patient or the physicians, do no allow the patient to come in contact with grounded metal objects during activation.When activating the unit, do not allow direct skin contact between the patient and the physician." there has been one additional complaint recorded for a similar incident with 6,968 sold since 2016.This is a complaint rate of (0.02%).Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any additional patient or user involvement or the need for corrective actions, a follow up report will be submitted.
Event or Problem Description
The customer alleged that the nurse experienced an electrical burn while she was holding the skin away from the tip by non-insulated forceps.

• Brand Name: BOVIE
• Common Device Name: DESSICATOR
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• MDR Report Key: 11379775
• Report Number: 3007208013-2021-00008
• Device Sequence Number: 4568608
• Product Code: GEI
• UDI-Device Identifier: 00607151011178
• UDI-Public: 00607151011178
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K161134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: A942
• Device Catalogue Number: A942
• Device Lot Number: 34074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1