MAUDE Adverse Event Report: BOVIE MEDICAL CORP TELEFLEX; ENT BLADE ELECTRODE

Catalog Number	809335
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer confirmed there was buildup of eschar on the device during the time of the event.Complaint confirmed from information received from customer.Root cause is user error in not removing flammable material from activation site.Per attached ifu: "fire hazard: the sparking and heating associated with electrosurgery can provide an ignition source.Observe fire precautions at all times: tissue buildup (eschar) on the tip of an active electrode poses a fire hazard, especially in oxygen enriched environments.With sufficient heating, eschar can become a glowing ember and pose a fire hazard both as an ignition source and as a fuel.Keep the electrode clean and free of all debris." this is the first complaint recorded for this occurrence.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 follow up report will be submitted.
Event or Problem Description
The customer alleged that while completed a left video assested thoracoscopy, left lower lobe completion lobectomy, mediastinal lymph node dissection the user was making an incision.Eschar remained on the tip of the electrode and when activated again, the eschar ignited for 2 seconds causing a flame.The surgeon put out the flame and stopped using the device.There was no harm to the user or patient.

• Brand Name: TELEFLEX
• Common Device Name: ENT BLADE ELECTRODE
• 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: 16463614
• Report Number: 3007208013-2023-00009
• Device Sequence Number: 12390834
• Product Code: GEI
• UDI-Device Identifier: 24026704736076
• UDI-Public: 24026704736076
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K942986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Catalogue Number: 809335
• Device Lot Number: 0421G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown