MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; CAUTERY

Catalog Number AA01

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

We have received limited information from the end user.We are continuing to follow up.As of 1/01/2021 there have been 3 similar incidences with (b)(4) cauteries sold.Once we have received additional information, a follow up report will be submitted.

Event Description

The customer alleged that the cauteries are getting hot and sparking when in use.

Manufacturer Narrative

Received the complaint through an mdpr in canada.Product was purchased on order number 958277 on (b)(6) 2022 by ndc.Product was shipped on invoice number 1197108 on 11/15/2022 line 10.Product was sold to canada distributor on po# 4600078342.Product was sold to end user on an unknown date.Customer stated they were attempting to use the devices, but for 3 eaches, the device was causing sparks when held initially active.Devices were received through the rma room on 6/1/2023.Devices were in good overall condition, with the tips slightly bent.One device had the button pushed in and broken.2 devices were received with corrosion in the battery pack, preventing further activation.1 devices returned would not activate at all, as the button had fallen in.This is not representative of the complaint from the customer, and we are unaware if the items were in this state (corrosion) prior to international return shipment.Customer was asked again about information for use of the device on (b)(6) 2023 since testing of the devices could not confirm the complaint.Customer responded stated they have been a long time user of the device with no changes in environment or users.Customer stated they had this issue out of box, where the three devices were selected for use, but sparked when activated.Initial complaint case was unable to be confirmed, as the products returned were not in operating condition.Other issues (battery corrosion) was confirmed from the returned units.True root cause for the issues experienced by the customer were unable be confirmed with accuracy.It may be possible this was an issue caused by a failed/damaged battery.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: BOVIE
• Type of Device: CAUTERY
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 16988860
• MDR Text Key: 316710338
• Report Number: 3007208013-2023-00021
• Device Sequence Number: 1
• Product Code: HQP
• UDI-Device Identifier: 10607151011014
• UDI-Public: 10607151011014
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: AA01
• Device Lot Number: 0522X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• 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