MAUDE Adverse Event Report: BOVIE MEDICAL CORP. CAUTERY HIGH TEMPERATURE ELONGATED TIP; DISPOSABLE CAUTERY

Model Number	AA21
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are still trying to get more information, some questions answered, and see if the devices can be returned.The investigation is ongoing.Once we have any additional relevant information, it will be submitted in a supplemental report.Please note that this report covers all three instances currently, as we have no details at all about the separate incidents.The three instances are tracked under (b)(4).
Event or Problem Description
Complainant alleges "filament issue and fell apart.3 instances of note to date, happened during 3 different procedures.".
Additional Manufacturer Narrative
The device was not returned for evaluation, and no pictures of the device were provided.The complaint was unable to be confirmed, and the root cause is unable to be determined.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: CAUTERY HIGH TEMPERATURE ELONGATED 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: 22898122
• Report Number: 3007208013-2025-00044
• Device Sequence Number: 8985194
• Product Code: HQP
• UDI-Device Identifier: 00607151011215
• UDI-Public: 00607151011215
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,Followup
• Report Date (Section B): 10/16/2025

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: AA21
• Device Lot Number: 0524Z
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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