MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; HIGH TEMP CAUTERY

Catalog Number AA01

Device Problem Temperature Problem (3022)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

Product was purchased on an unknown order number through medline.Traceability by lot number was not possible as no samples were available, and the lot number remained unknown.Customer stated cautery caused burn to patient initially.On (b)(6) 2023, customer gave response to mdr questions.Customer stated: a flash (spark) was born to eye lid and lashes during activation of the device.Customer was unsure if the spark was caused by the eye lashes or presence of oxygen.The device was just activated, and held active for a matter of seconds when trying to cauterize the eye lid.Surgery was a blow (blepharoplasty) and occurred on (b)(6) 2023 and the patient received a mild burn.Customer did confirm this was an oxygen rich environment.Complaint confirmed.Root cause is determined to be user error.Via ifu, mc-23009 rev 9 - "do not use in the presence of flammable gases/materials or in oxygen rich environments.Fire could result.".Product was used in an oxygen rich environment, near human eye lashes, which are also known to be a flammable material.Since (b)(6) 2021, this is the second complaint of its kind for unintentional burns.In the same time period, we sold 603230 eaches.0.00033%.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 additional information pertinent to the investigation, a follow up report will be submitted.

Event Description

The customer alleged that while they were cauterizing the eyelid, the cautery sparked and caused a burn to eyelid and burned the patient's lashes.The patient received a minor burn with no additional intervention required.

• Brand Name: BOVIE
• Type of Device: HIGH TEMP 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: 16988861
• MDR Text Key: 315849215
• Report Number: 3007208013-2023-00022
• Device Sequence Number: 1
• Product Code: HQP
• UDI-Device Identifier: 10607151011014
• UDI-Public: 10607151011014
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2023

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 Catalogue Number: AA01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1