MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION BOVIE; EXTENDED MODIFIED BLADE ELECTRODE

Model Number	ES39
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was initially received on (b)(6) 2020.At the time of this complaint, the decision was made that the complaint did not require a report to the fda.The distributor in (b)(4) agreed at the time.On 7/24/2020 the distributor in (b)(4) sent us an email stating that they made the decision to report in (b)(4).As a response to the report our regulatory group decided the us should report as well.The product was not returned for evaluation.The dhr record was reviewed for lot number 0118c and there were no noted noncomformities during manufacturing and processing of this product and lot number.All items were noted as within manufacturing specification from the manufacturer.The product was purchased through bovie medical prior to the acquisition on (b)(6) 2018.The product was not returned for evaluation: based on the information provided by the customer, it was determined that the electrode became too hot as a result of using it on a child less than 25 lb.Additionally, it is recommended that this device be used on the lowest setting possible.There is a possibility that the electrode was used for an extended period of time without rest at a setting that was too high and it became too hot as a result.(b)(4).Based on this information, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions, a follow up report will be submitted.
Event or Problem Description
While using the electrode in the mouth of a child patient, the black protection covering the electrode melted.There was no adverse consequence for the patient.

• Brand Name: BOVIE
• Common Device Name: EXTENDED MODIFIED BLADE ELECTRODE
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater, fl
• MDR Report Key: 10411388
• Report Number: 3007208013-2020-00020
• Device Sequence Number: 3273761
• Product Code: HGI
• UDI-Device Identifier: 00607151056391
• UDI-Public: 00607151056391
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K942986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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 Expiration Date: 01/01/2022
• Device Model Number: ES39
• Device Catalogue Number: ES39
• Device Lot Number: 0118C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/14/2020
• Patient Sequence Number: 1