MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; HIGH FREQUENCY GENERATOR

Model Number	SERF
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint stemmed from voluntary medwatch report # mw5106089 that gyrus received from the fda.The report did not include any end customer informaiton or any additional details regarding the incident or lot number information for tracking.Without any additional information, an investigation cannot be completed.Therefore, the complaint cannot be confirmed and root cause cannot be determined.This is the first complaint recorded of this kind, making this an isolated event.Based on the above information, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement, or need for a corrective actions, a follow up report will be submitted.
Event or Problem Description
The only information received was maude watch report that states that there was a possible injury that required intervention.The even description was "break".

• Brand Name: BOVIE
• Common Device Name: HIGH FREQUENCY GENERATOR
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton rd; clearwater FL 33760
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 14361936
• Report Number: 3007208013-2022-00019
• Device Sequence Number: 5057905
• Product Code: GEI
• UDI-Device Identifier: 00607151001667
• UDI-Public: 00607151001667
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K001955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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: SERF
• Device Catalogue Number: 550015E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown