MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; ENT STANDARD BLADE ELECTRODE

Catalog Number	ES37
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that after approximately 1 minute of use, the patient experienced a superficial burn to the right corner of the lip while using the cautery.The facility applied bacitracin to the affected area and removed the cautery from the field.There was no further harm to the patient.
Additional Manufacturer Narrative
There has been a total of (b)(4) sold of all lots with no additional complaints recorded for this occurrence the device was returned to our nashville office and out of an abundance of caution the device was sent to the manufacturing location for review and testing.A follow up report will be submitted once we have received the investigation report.
Additional Manufacturer Narrative
No pictures were available of the burn site.Customer was given rma to return product for further review on (b)(6) 2023.Product was received into the rma room on date 3/9/2023.Product was inspected to find an almost like new device, with a very minimal amount of scratching on the tip of the electrode.Pencil used by end user was also returned.Out an abundance of caution, supplier of electrode was contacted for further electrical safety testing of the returned device.Rma was provided, and returned to supplier.Supplier provided the following/attached investigative response: visual inspection: there was some light scratching on the insulation near the tip.See photo.There was no evidence of a dielectric failure (blow thru hole) anywhere on the insulation.Dielectric insulation testing: both the main blue grip insulator and black kynar insulation the electrode was tested for any pinholes, gaps or any other breach in the insulation.No breakdown was found.The area of the scratch, that was found during the visual inspection, was tested.Due to the fact that the scratch was near the tip of the electrode, electrical tape was used to insulate the bare tip to prevent the arcing.The hypot wand was run over the area of the scratch several times.No dielectric breakdown occurred.Complaint was unable to be confirmed at this time as returned product remained in specification.Root cause is unable to be determined with accuracy at this time, however, it may be possible the end user accidentally touched the patients lip while the electrode remained hot from activation, causing the minor burn.Based on the above information, no further actions are required.This can be seen as the final report, if additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: ENT STANDARD BLADE ELECTRODE
• 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: 16600901
• Report Number: 3007208013-2023-00013
• Device Sequence Number: 15000980
• Product Code: GEI
• UDI-Device Identifier: 10607151056374
• UDI-Public: 10607151056374
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K942986
• 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,Followup
• Report Date (Section B): 04/05/2023

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: Health Professional
• Device Expiration Date: 05/01/2025
• Device Catalogue Number: ES37
• Device Lot Number: 0521A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown