MAUDE Adverse Event Report: BOVIE MEDICAL CORP. BOVIE SPECIALIST PRO HIGH FREQ ELECTROSURGICAL GENERATOR

Model Number	A1250S
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and sent out for testing and repair.The investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "issue: unit is connected properly, but not getting any cauterization.Tried multiple different active cables and grounding pads, but nothing worked.".
Additional Manufacturer Narrative
The device was returned for evaluation and repair.Full factory testing was conducted and the unit was found to be functioning properly.No device problem found.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: BOVIE SPECIALIST PRO HIGH FREQ ELECTROSURGICAL GENERATOR
• Common Device Name: ELECTROSURGICAL GENERATOR
• 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: 23771379
• Report Number: 3007208013-2025-00069
• Device Sequence Number: 13192396
• Product Code: GEI
• UDI-Device Identifier: 00607151010263
• UDI-Public: 00607151010263
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022856
• 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): 01/13/2026

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: A1250S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown