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

Model Number	231
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in process of getting similar devices returned (actual device discarded) for evaluation.The investigation is ongoing.Once we have additional relevant information it will be wubmitted in a supplemental report.
Event or Problem Description
Complainant alleges "on item, provider pressed green button and item was heating up and glowed up.When provider went to use it on patient, the tip bent and fell off.Provider and patient were both unharmed.".
Additional Manufacturer Narrative
The actual device was not returned for evaluation.However, based on information from reporter, the complaint was able to be confirmed.The user was using the device to drain a subungual hematoma, which is not an approved use of the product.The root cause is determined to be off label use of the device.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: MCKESSON 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: 23005243
• Report Number: 3007208013-2025-00048
• Device Sequence Number: 10516616
• Product Code: HQP
• UDI-Device Identifier: 10612479209029
• UDI-Public: 10612479209029
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/19/2025

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: 231
• Device Lot Number: 0124Y
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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