MAUDE Adverse Event Report: BOVIE MEDICAL CORP. ELECTROSURGICAL GENERATOR + HIGH FREQUENCY DESSICATOR

Model Number	A952
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Actual device is in process of being returned for evaluation.The investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "during a procedure the unit arced and burned a patient.".
Additional Manufacturer Narrative
The device was not returned for evaluation.The complaint could not be confirmed, and the root cause cannot be determined.This should be considered the final report.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: ELECTROSURGICAL GENERATOR + HIGH FREQUENCY DESSICATOR
• 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: 22293560
• Report Number: 3007208013-2025-00028
• Device Sequence Number: 8875420
• Product Code: GEI
• UDI-Device Identifier: 00607151011161
• UDI-Public: 00607151011161
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K161134
• 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): 09/23/2025

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: A952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male