MAUDE Adverse Event Report: BOVIE MEDICAL CORP. CHANGE-A-TIP DELUXE HIGH; CAUTERY

Model Number	DEL1
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
The actual device is in process of being returned for evaluation.The model number and lot number were provided.The investigation is ongoing.Once we have completed the investigation, a supplemental report will be submitted with any additional relevant information.
Event or Problem Description
Complainant alleges "when the metal element was heated up to start the surgery, the heated tip broke and flew about 30cm away.Thankfully it landed on a piece of hygiene roll covering the patient and not on the patient or a staff member.One of the replacement tips included in the del-1 kit was used to complete the surgery with no complications.".
Additional Manufacturer Narrative
The actual device was returned for evaluation, but was returned without any of the tips.The device batteries were tested and were within specification.The customer was unable to supply specific information about the duty cycle of the device.Root cause is unable to be determined without further information about the duty cycle of the device.The complaint was confirmed, but root cause was undetermined.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: CHANGE-A-TIP DELUXE HIGH
• Common Device Name: 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: 21283369
• Report Number: 3007208013-2025-00003
• Device Sequence Number: 9339804
• Product Code: GEI
• UDI-Device Identifier: 00607151045012
• UDI-Public: 00607151045012
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K840433
• 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): 03/17/2025

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: DEL1
• Device Lot Number: 2023-10-02
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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