MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; CAUTERY

Model Number	AA01
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer alleges that aa01 has ignited during use when cauterizing "folds" which then caught on fire causing danger to staff and patient.Patient received minor burns to face.
Additional Manufacturer Narrative
Complaint event occurred on (b)(6) 20221.End customer did not notify distributor till a later date.Distributor made symmetry aware of event on (b)(6) 2022.Customer supplied the following information about the complaint: plastic surgeon was completing removal of a mole on the facial area.Aa01 cautery was used to stop the bleeding.User ignited some basic gauze while cauterizing the blood vessels where the mole was removed.Patient received burns to the forehead, round in shape about 1 cm.No serious injury, life threatening event, hospitalization, or death occurred.However, it is not known if a scar will result due to the burn.Device was only active for a few seconds.It was not active more than active, stated by the customer.No true cycles of activation were given.Product was inspected briefly prior to use, but not documented.Product lot number remains unknown.Product was destroyed after use, therefore pictures or return is not possible.Root cause is believed to be accidental user error in operating the cautery to close to flammable materials.According to the ifu, mc-23009 revision 8, "do not use in the presence of flammable gases/materials or in oxygen rich environments.Fire could result.Cautery produces heat in excess of 1000 degrees f, which can cause burns or fire from misuse.Accidental exposure to cautery tip may lead to inadvertent burns to patient or user." there has been a total of (b)(4) sold since 2016 with 4 complaints received for similar occurrences.((b)(4) complaint rate) based on the above information, this report 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.

• Brand Name: BOVIE
• Common Device Name: CAUTERY
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton corp; 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: 14700414
• Report Number: 3007208013-2022-00022
• Device Sequence Number: 5057913
• Product Code: GEI
• UDI-Device Identifier: 00607151011017
• UDI-Public: 00607151011017
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K121441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2022

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: AA01
• Device Catalogue Number: AA01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown