MAUDE Adverse Event Report: BOVIE MEDICAL CORP. CAUTERY HIGH TEMP LOOP TIP; DISPOSABLE CAUTERY

Model Number	AA03
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are attempting to get the device sent back for evaluation, and to gather additional information.The investigation is ongoing.
Event or Problem Description
Complainant alleges "aa03 cautery caught fire and caused a small burn for the patient.".
Additional Manufacturer Narrative
The device was discarded and unable to be returned for evaluation.No pictures of the device were provided, the lot code was not provided, and we were unable to get answers about the duty cycle used.True root cause is unable to be determined at this time due to the limited information provided.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: CAUTERY HIGH TEMP LOOP TIP
• Common Device Name: DISPOSABLE CAUTERY
• Manufacturer (Section D): BOVIE MEDICAL CORP.; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: terry hall ; 5115 ulmerton road; clearwater, FL 33760 ; 6166987100
• MDR Report Key: 22437895
• Report Number: 3007208013-2025-00029
• Device Sequence Number: 4745718
• Product Code: HQP
• UDI-Device Identifier: 00607151011031
• UDI-Public: 00607151011031
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: AA03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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