MAUDE Adverse Event Report: BOVIE MEDICAL CORP. CAUTERY HIGH TEMP 2IN EXTENDED SHAFT LOOP TIP; DISPOSABLE CAUTERY

Model Number	AA05
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "activation button collapsed into device when attempted to use.".
Additional Manufacturer Narrative
The actual device is not available for evaluation.The investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The actual device was unable to be safely returned and sterilized for evaluation.Pictures of the device were provided, but the lot number remains unknown.The complaint was able to be confirmed from the pictures, however the true 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 TEMP 2IN EXTENDED SHAFT LOOP TIP
• Common Device Name: DISPOSABLE CAUTERY
• Manufacturer (Section D): BOVIE MEDICAL CORP.; 5115 ulmerton road; clearwater 33760
• Manufacturer Contact: terry hall ; 5115 ulmerton road; clearwater, FL 33760 ; 6166987100
• MDR Report Key: 22787622
• Report Number: 3007208013-2025-00041
• Device Sequence Number: 18202026
• Product Code: HQP
• UDI-Device Identifier: 00607151011055
• UDI-Public: 00607151011055
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: AA05
• Device Lot Number: UNKNOWN
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 08/20/2025
• 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