MAUDE Adverse Event Report: BOVIE MEDICAL CORP. BOVIE MEDICAL; GENERATOR

Model Number	A1250S
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting return of the reported device and/or additional information to complete the evaluation.
Event or Problem Description
The complainant alleges, "today the machine sparked fire (flame) from the front connection plug for the foot control.".
Event or Problem Description
The complainant alleges, "today the machine sparked fire (flame) from the front connection plug for the foot control.".
Additional Manufacturer Narrative
Unit was received and serviced by the repair department on 05/20/2024.The complaint was not confirmed.No evidence was found for any sparking, or burning on the front panel connections during initial checks of the unit.The main board was removed from the unit and examined with no evidence found for sparking or burning inside the unit.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.

• Brand Name: BOVIE MEDICAL
• Common Device Name: GENERATOR
• Manufacturer (Section D): BOVIE MEDICAL CORP.; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP.; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 19410555
• Report Number: 3007208013-2024-00023
• Device Sequence Number: 20974236
• Product Code: GEI
• UDI-Device Identifier: 00607151010263
• UDI-Public: 00607151010263
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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
• Device Model Number: A1250S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown