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

Model Number	A2350
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Arrhythmia (1721)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting return of the reported device and/or additional information from the complainant to complete the evaluation.
Event or Problem Description
The complainant alleges, "when using the a2350 it caused a cardia arrhythmia on the patient.The patient did not have a pacemaker or implanted defibrillator.Used a different generator to complete the procedure.".
Additional Manufacturer Narrative
The reported device was returned to the repair facility where 100% diagnostic tested was completed.Device was tested through burn ins and no irregularity was found from the generator.No issues were found with the generator and the complaint was unable to be confirmed.A dhr review was completed for product a2350 with serial number (b)(6).There were no noted nonconformities during manufacturing and processing of this product.All items were noted as within manufacturing specification from the manufacturer.Root cause is unable to be determined at this time.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 CORP.
• Common Device Name: ELECTROSURGICAL 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: 18946399
• Report Number: 3007208013-2024-00012
• Device Sequence Number: 7084362
• Product Code: GEI
• UDI-Device Identifier: 10607151010031
• UDI-Public: 10607151010031
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: A2350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/04/2024
• 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