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

Model Number	244
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device is not available for evaluation.The investigation is ongoing.Once additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "customer stated at least 3 of the tips from this product have broken off while in use.One caused tissue injury on patient.The procedure was expanded to remove the damaged tip, which resulted in a longer incision, longer procedure time, and longer healing time.".
Additional Manufacturer Narrative
The device has been returned for evaluation, and the investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The device was returned for evaluation.Root cause is determined to be a manufacturing error, where the tip does not have enough gap between the two wires, leading the device to short path and the tip to break.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: MCKESSON CAUTERY HIGH TEMP 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 raod; clearwater, FL 33760 ; 6166987100
• MDR Report Key: 23606638
• Report Number: 3007208013-2025-00063
• Device Sequence Number: 21146908
• Product Code: HQP
• UDI-Device Identifier: 10612479209067
• UDI-Public: 10612479209067
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 244
• Device Lot Number: 0524Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/23/2025; 01/23/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male