MAUDE Adverse Event Report: BOVIE MEDICAL CORP. BOVIE® SURGI-CENTER PRO HIGH FREQ GENERATOR; ELECTROSURGICAL GENERATOR

Model Number	A2350
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in process of trying to get the device returned for evaluation 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 "not producing power to bovie handle.".
Additional Manufacturer Narrative
The unit was returned for evaluation and repair.Upon evaluation, the reported issue was confirmed, and the unit would require a new main pcb.The customer decided not to proceed with the repair, and so the unit was sent back to the customer unrepaired.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: BOVIE® SURGI-CENTER PRO HIGH FREQ 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: 23916336
• Report Number: 3007208013-2025-00077
• Device Sequence Number: 9194628
• Product Code: GEI
• UDI-Device Identifier: 00887482188873
• UDI-Public: 00887482188873
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K134054
• 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): 04/08/2026

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: A2350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 04/08/2026
• 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