MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; HIGH FREQUENCY GENERATOR

Model Number	A940
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was purchased on an order number prior to acquisition by symmetry surgical.A940 product is no longer available for sale.Customer stated they were completing a biopsy of skin on a patient with beard, when beard was caught on fire.Customer was contacted for information about the event, however, they were unwilling to answer any investigative questions.Complaint is unable to confirmed at this time.Root cause is unable to be determined with accuracy, however, it is believed this is a possible user error related event in not following the below precautions stated in a940 ifu, (b)(4).Fire / explosion hazard - the following substances will contribute to increased fire and explosion hazards in the operating room: flammable substances (hair is considered a flammable substance).The sparking and heating associated with electrosurgery can provide an ignition source.Observe fire precautions at all times.When using electrosurgery in the same room with any of these substances or gases, prevent their accumulation or pooling undersurgical drapes, or within the area where electrosurgery is performed.Based on the above information, 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 customer alleged, that while using the a940 device on a bearded person, the hair of the beard caught fire and caused a burn to the patient.

• Brand Name: BOVIE
• Common Device Name: HIGH FREQUENCY GENERATOR
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 13544450
• Report Number: 3007208013-2021-00038
• Device Sequence Number: 11985689
• Product Code: GEI
• UDI-Device Identifier: 10607151005334
• UDI-Public: 10607151005334
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K000961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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: A940
• Device Catalogue Number: A940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown