MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION RESISTICK; BLADE ELECTRODE

Model Number	ES37
Health Effect - Clinical Code	Burn, Thermal (2530)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of the incident is unknown and pictures were not provided.Without the information requested, the physical device to evaluate, or pictures of the device, a root cause cannot be determined.The device history record was reviewed with no issues found in the manufacturing or processing of the devices.There has been a total of (b)(4) sold of this product code since 2016 with one additional complaint recorded for a similar occurrence.This is a complaint rate of (b)(4) which is categorized as a low probability.Based on this information, this complaint can be closed and no additional 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 corrective actions, a follow up report will be submitted.
Event or Problem Description
The doctor was using the blade electrode on the patient when the blade part burned through the rubber and burned the patient's mouth.

• Brand Name: RESISTICK
• Common Device Name: BLADE ELECTRODE
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• MDR Report Key: 10985116
• Report Number: 3007208013-2020-00038
• Device Sequence Number: 3486760
• Product Code: GEI
• UDI-Device Identifier: 00607151056377
• UDI-Public: 00607151056377
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093025
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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): 12/02/2020

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: 02/01/2024
• Device Model Number: ES37
• Device Catalogue Number: ES37T
• Device Lot Number: 0220D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/10/2020
• Patient Sequence Number: 1