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

Model Number	AA01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "the device was used during thoracic vascular replacement surgery for the purpose of creating a hole in the artificial graft.Due to a breakage in the lead wire at the tip, electrical conduction did not occur.The product was replaced with a second unit of the same model from a different lot; however, the same issue occurred with the second unit.No alternative product was used, and the procedure was completed.".
Additional Manufacturer Narrative
The device was not returned for evaluation.Based on information provided by the end user, the complaint could be confirmed.Root cause was off-label use by the user, as it is not approved for punching holes in prosthetic grafts and may break easily when used for that off-label use.This should be considered the final report.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: CAUTERY HIGH TEMP FINE 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: 23820922
• Report Number: 3007208013-2025-00071
• Device Sequence Number: 9332016
• 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): 12/16/2025

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: 0425X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/16/2025
• 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