MAUDE Adverse Event Report: BOVIE MEDICAL BOVIE; RESISTICK II COATED MOD BLADE ELECTRODE 2.75"

Catalog Number	ES37T
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We believe that the electrode was activated for a longer period of time in comparison to the time specified in the generator ifu.General operating principle stated in ifu mc-55-232-001 revision 3 states "under maximum power settings and rated load conditions (cut i, 200 watt @ 300 ohm load), the generator is suitable for activation times of 10 seconds on followed by 30 seconds off for 30 minutes." customer was using device for one minute at a time with only 30 seconds of relax time.This has allowed the electrode to become very hot, which may have had accidental contact with the patient, causing the burn.The lot number is unknown for this device.Historical sales prior to the bovie purchase were (b)(4) units since (b)(6) 2016.Since the bovie purchase, we have sold (b)(4) units starting in (b)(6) 2018.Bovie received 1 complaints of the same issue since (b)(6) 2016 and this is the 3rd complaint that we have received for the same issue.(b)(4).Based on this information, this can been seen as the final report.If additional information is received that alleges additional patient involvement or need for corrective actions, a follow up report will be submitted.
Event or Problem Description
The customer alleged "the doctor was using on patient the blade part burned the patients mouth." the was no additional medical intervention was necessary.

• Brand Name: BOVIE
• Common Device Name: RESISTICK II COATED MOD BLADE ELECTRODE 2.75"
• Manufacturer (Section D): BOVIE MEDICAL; 5115 ulmerton rd; clearwater FL 33760
• MDR Report Key: 11477835
• Report Number: 3007208013-2021-00011
• Device Sequence Number: 3828544
• Product Code: GEI
• UDI-Device Identifier: 10607151005754
• UDI-Public: 10607151005754
• 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): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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 Catalogue Number: ES37T
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1