MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; HIGH TEMP CAUTERY

Model Number	AA01
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that while using the bovie it appeared to set fire to a piece of gauze.The gauze was sparked and caused a flame to burn off some of the patient's eyebrow.There was no additional effect on the patient.
Additional Manufacturer Narrative
Product was purchased by orc through multiple order numbers.Product was sold to end user on an unknown date.Customer claims that during use of the cautery during a blepharoplasty on the right eye, the cautery came into contact with the gauze.Gauze was sparked and caused flame to burn off some of the patients eyebrow.Customer gave the following information about use: date of operation was (b)(6) 2022.The device was used in multiple activation timings, with no one set time period used.The intended area for cauterization was the eyelid skin.No oxygen mask was present.However, gauze was present over the eyebrow next to the eyelid being cauterized.No delay in surgery, instrument did not break in two pieces, there was no death or serious injury, no disability of permanent damage.There are no pictures of the patient burned eyebrow hair.Another method was used to complete the surgery.Complaint confirmed from information received from the end user.Root cause is determined to be user error in not following the ifu properly.According to ifu (b)(4) at 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 gauze with the tip of the cautery activated caused a spark of the gauze.There has been a total of (b)(4) cauteries sold with (b)(4) additional complaint recorded with similar occurrences ((b)(4)).Based on the complaint investigation, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or information pertinent to the investigation, a follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: HIGH TEMP CAUTERY
• 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: 15307175
• Report Number: 3007208013-2022-00037
• Device Sequence Number: 5374567
• Product Code: GEI
• UDI-Device Identifier: 00607151011017
• UDI-Public: 00607151011017
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 0721E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown