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

Model Number	AA21
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "the doctor went to use one of the cauterizing pens this morning and it's completely defective.They weren't able to use it so we had to open up another one when i got to the clinic.".
Additional Manufacturer Narrative
The device is not available for evaluation.The investigatiion is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The device was not returned, however pictures of the device were provided and the complaint was able to be confirmed.Based on review of the pictures, it was found that the tip filament had overlapped, causing the tip to break and no longer be able to complete a circuit.It is unable to be determined when or how this happened.Root cause is unable to be determined, as further information was attempted to be obtained from the end user, but was unsuccessful.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 raod; clearwater FL 33760
• Manufacturer Contact: terry hall ; 5115 ulmerton road; clearwater, FL 33760 ; 6166987100
• MDR Report Key: 22894409
• Report Number: 3007208013-2025-00043
• Device Sequence Number: 14949027
• Product Code: HQP
• UDI-Device Identifier: 00607151011215
• UDI-Public: 00607151011215
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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: 07/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/26/2025
• 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