MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION SELECT; HIGH FREQUENCY GENERATOR

Model Number	22-A952
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the device is unknown.There has been a total of (b)(4) sold since january 2016 and with this being the second complaint recorded for a similar occurrence.The unit is being returned to our repair facility for evaluation and repair.Once we have received the repair details, a follow up report will be submitted.
Event or Problem Description
The bovie select 247 high frequency desiccator gave out during a procedure.There was a delay in the procedure as a result, but there was no harm to the patient.
Additional Manufacturer Narrative
Added the product serial number (b)(6).The product was returned to clearwater florida for evaluation and repair.During the evaluation, it was confirmed that the unit had an e2 error when turned on.It was confirmed that the nylon cap washers are loose inside the unit and the encoders were broken.This type of damage is the result of normal wear and tear of the unit.The unit was repaired and returned to the customer.The generator was manufactured in january 2016 and has therefore been in use for approximately 4 years.Based on this information, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions a follow up report will be submitted.
Additional Manufacturer Narrative
Corrected the manufacture date from (b)(6) 2016 to (b)(6) 2007.This date was entered incorrectly in the last follow up report.

• Brand Name: SELECT
• Common Device Name: HIGH FREQUENCY GENERATOR
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater, fl
• MDR Report Key: 9825642
• Report Number: 3007208013-2020-00006
• Device Sequence Number: 13641818
• Product Code: GEI
• UDI-Device Identifier: 20612479212927
• UDI-Public: 20612479212927
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2020

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: 22-A952
• Device Catalogue Number: 247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020; 02/14/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/20/2020; 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1