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

Model Number	AA01
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation, no pictures of the device were provided, and specific questions regarding activation timing were not answered.The complaint could not be confirmed, and root cause is undetermined.This should be considered the final report.If additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges: "patient was undergoing office vasectomy.Handheld cautery was being used.I noted that the cautery seemed to be producing more heat and smoke than usual, and i noted warmth on my hand while using it.It also burned 2 marks on the drape on the back table when it was set down, despite the tip not being in direct contact with the drape.Subsequently, a raytec that was not in direct contact with the cautery (at least 3 inches away) appeared to have some brown color changes so i picked it up off the patient to examine it.It began to smoke.While walking over to the sink with raytec in hand, the raytec caught on fire.I dropped it in the sink and the fire was put out with water.".

• Brand Name: CAUTERY HIGH TEMP FINE TIP
• Common Device Name: HIGH TEMP 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: 22194409
• Report Number: 3007208013-2025-00025
• Device Sequence Number: 15610428
• Product Code: HQP
• UDI-Device Identifier: 00607151011017
• UDI-Public: 00607151011017
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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: AA01
• Device Lot Number: 0824Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/12/2025
• 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: Male