MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION BOVIE; CAUTERY

Model Number	AA01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned from the customer for evaluation.The customer could not confirm that the correct duty cylce that is stated in the ifu was being followed.The recommended duty cycle is 2 seconds on and 6 seconds off for a continuous time of no longer than 15 minutes.Use beyond the recommended cycle could result in the device becoming too hot.The device history record for the product lot number was reviewed.There were no noted noncomformities concerning batteries during manufacturing and processing of this product and lot number.All items were noted as within manufacturing specification from the manufacturer.There has been a total of (b)(4) sold of this product with one additional complaint received since 2016.(b)(4) complaint rate).Based on the above 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
The facility received two accounts of the cautery pens forming a spark during a case.There was no harm to the patient.

• Brand Name: BOVIE
• Common Device Name: CAUTERY
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• MDR Report Key: 10512192
• Report Number: 3007208013-2020-00026
• Device Sequence Number: 2940620
• Product Code: HQP
• UDI-Device Identifier: 00607151011017
• UDI-Public: 00607151011017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121441
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 12/01/2023
• Device Model Number: AA01
• Device Catalogue Number: AA01
• Device Lot Number: 1219E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1