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

Model Number	AA01
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation, and no pictures were provided so the complaint could not be confirmed.True root cause is unable to be determined, however the intended use by the customer is an off-label use and that is most likely the cause of the malfunction.This should be considered the final report.If any additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "the cautery was selected for use to punch a hole to a prosthetic vessel graft.The first product became too hot, so the tip of the cautery melted.The cautery was replaced with the same lot#'s one.The tip of the second product was found to have been broken from the beginning.The 3rd cautery was used to proceed the procedure.No adverse health consequence to the patient was reported.".

• Brand Name: CAUTERY HIGH TEMP FINE TIP
• Common Device Name: BATTERY POWERED 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: 23547922
• Report Number: 3007208013-2025-00061
• Device Sequence Number: 18462564
• Product Code: HQP
• UDI-Device Identifier: 00607151011017
• UDI-Public: 00607151011017
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: 0325Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2025
• Initial Report FDA Received Date: 11/13/2025
• 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