MAUDE Adverse Event Report: BOVIE MEDICAL BOVIE; DIPOSABLE ELECTROSURGICAL PENCIL WITH BLADE AND HOLSTER

Catalog Number	ESP1H
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporter alleged: "we had a patient burned on the inside of their cheek on (b)(6) 2021, with a bovie that malfunctioned during a tonsillectomy.The non-coated bovie tip had been switched out for a megadyne coated tip.The electrosurgical pencil is item # esp1h.I do not have the lot number for the pencil as the package was discarded.The generator is the aaron or pro 300, ref: (b)(4), sn: (b)(4)." the pencil was returned and evaluated, but no problem could be confirmed with the device.It performed as intended.We believe there are two possible root causes for the burn: the electrode was activated for a longer period of time in comparison to the time specified in generator ifu.General operating principle stated in ifu mc-55-230-001 revision 4 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." timing of use of the device was unknown by the reporter.Risidual heat from using the electrode for an unknown period of time may have led to the burns via touching the hot electrode to the patient.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 reporter alleged: "we had a pt burned on the inside of their cheek on (b)(6) 2021, with a bovie that malfunctioned during a tonsillectomy." the user was using an aaron or pro 300, a bovie esp1h push button pencil with a megadyne coated electrode.

• Brand Name: BOVIE
• Common Device Name: DIPOSABLE ELECTROSURGICAL PENCIL WITH BLADE AND HOLSTER
• Manufacturer (Section D): BOVIE MEDICAL; 5115 ulmerton rd.; clearwater FL 33760
• MDR Report Key: 11794081
• Report Number: 3007208013-2021-00017
• Device Sequence Number: 16374354
• Product Code: GEI
• UDI-Device Identifier: 10607151001442
• UDI-Public: 10607151001442
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K936304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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: ESP1H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1