MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION BOVIE; CAUTERY

Model Number AA01

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2020

Event Type  malfunction  

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 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
• Type of Device: CAUTERY
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 10512192
• MDR Text Key: 213248921
• Report Number: 3007208013-2020-00026
• Device Sequence Number: 1
• Product Code: HQP
• UDI-Device Identifier: 00607151011017
• UDI-Public: 00607151011017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1