MAUDE Adverse Event Report: BOVIE MEDICAL MCKESSON; PUSH BUTTON ELECTROSURGICAL PENCIL

Catalog Number	22-ESP1
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the device was not possible because the user cut the cord of the pencil.The lot and manufacture date of the device is unknown.The user was using our pencil with another manufacturer's generator and electrode.Root cause was not able to be determined.However, based on the user's response to our questionnaire, we believe that the end user may have had the pencil/electrode activated for a long period of time, leaving the electrode hot when using the device at 35w cut and coag generator settings.When the electrode is hot, possible site burns may occur if accidental contact is made with patient tissue.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 0 complaints of the same issue since (b)(6) 2016 and this is the first complaint that we have received for the same issue.Based on the above information, no further 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 user alleged that "a faulty bovie caused burns to a patient.I have the pencil here".The user is referring to our private label mckesson push button electrosurgical pencil.

• Brand Name: MCKESSON
• Common Device Name: PUSH BUTTON ELECTROSURGICAL PENCIL
• Manufacturer (Section D): BOVIE MEDICAL; 5115 ulmerton rd; clearwater FL 33760
• MDR Report Key: 11564915
• Report Number: 3007208013-2021-00014
• Device Sequence Number: 17146197
• Product Code: GEI
• UDI-Device Identifier: 10607151056312
• UDI-Public: 10607151056312
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: 22-ESP1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1