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

Model Number	A2350
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "the cautery unit will allow cautery pencil to be used when a grounding pad is not plugged in.The unit acts as though a cautery pad is plugged in even when one is not plugged in.The unit intermittently will not recognize when a cautery pad is plugged in.".
Additional Manufacturer Narrative
The device is in process of being returned for evaluation and repair.The investigation is ongoing.Once additional relevant information is identified, it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The device was returned for evaluation and repair.The issue was confirmed, and the problem was that the main pcb had a resistor which completely disconnected from the board.The main pcb was replaced and based on full factory testing the issue was resolved and the device was sent back to the customer.The root cause was an electrical component failure.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: 23646535
• Report Number: 3007208013-2025-00064
• Device Sequence Number: 21363225
• Product Code: GEI
• UDI-Device Identifier: 00887482188873
• UDI-Public: 00887482188873
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/18/2025

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: A2350
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown