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

Model Number	231
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.It appears the tip heating element - when used/applied to patient - had the wire touch itself, leading to the destruction of the tip.The customer stated that the device was held active for a few minutes.The root cause of why the tip broke is believed to be misuse of the device in activating the device longer than intended per the ifu.Per ifu, the recommended duty cycle is 2 seconds on and 6 seconds off for a continuous time of no longer than 15 minutes.This should be considered the final report.If any additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "during a procedure, the physician was in the process of cauterizing a wound on the patient's left shin using a surgical cautery mckesson argent¿ fine tip high temperature device.Upon contact with the patient, the first tip exploded.A second tip was retrieved and used, but it also exploded upon contact.A third tip, sourced from a different lot number, was then used.No issues were reported with this tip, and the procedure continued without further incident.".

• Brand Name: ARGENT 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: 23311443
• Report Number: 3007208013-2025-00057
• Device Sequence Number: 20284184
• Product Code: HQP
• UDI-Device Identifier: 10612479209029
• UDI-Public: 10612479209029
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: 231
• Device Lot Number: 0124Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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