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

Model Number	A1250S
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation, and it was sent for repair.The unit was subjected to full factory testing and found to be functioning properly prior to returning to the customer.All tests passed, and we were unable to confirm the complaint and root cause is undetermined.This should be considered the final report.If any additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "previously had a leep procedure where the machine wasn't cutting as well as it used to a few weeks ago so she upped her settings from 40/40 to 50/50.This time, the machine stopped working mid cut.You could hear her cutting the tissue, the machine stopped abruptly while she was still pressing the button on the hand controller and then it started up again.".

• Brand Name: BOVIE SPECIALIST PRO HIGH FREQUENCY GENERATOR
• Common Device Name: ELECTROSURGICAL GENERATOR
• Manufacturer (Section D): BOVIE MEDICAL CORP.; 5115 ulmerton raod; clearwater FL 33760
• Manufacturer Contact: terry hall ; 5115 ulmerton road; clearwater, FL 33760 ; 6166987100
• MDR Report Key: 23586962
• Report Number: 3007208013-2025-00062
• Device Sequence Number: 9259972
• Product Code: GEI
• UDI-Device Identifier: 00607151010263
• UDI-Public: 00607151010263
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 11/18/2025

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: A1250S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/18/2025
• 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