MAUDE Adverse Event Report: BOVIE MEDICAL CORP MCKESSON; COATED BLADE ELECTRODE

Catalog Number	22-ES59T
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that during the first use of the device, the coating melted and fell off.The problem occurred durint a neur surgery.There was no harm to the patient, however there was a potential for harm if it would have fell into the surgical site.
Additional Manufacturer Narrative
Product was purchased on order number (b)(4).On (b)(6).2023.Product was shipped on invoice number (b)(4).On(b)(6).2023 line 17 customer was using the device in a neuro surgery at 30 watts coag.The customer confirmed there was no consequence to patient.Product was returned through the rma room on (b)(6).2023 complaint confirmed based on information provided from the customer.Root cause is determined to be customer miss-use at a high power settings with unknown activation timings.From the ifu, mc-23202 revision1 - "use of electrode with modified insulation in contact with tissue or fluid may cause splitting or peeling back of the modified insulation on the electrode.· always use the lowest power setting that achieves the desired surgical effect.Use the active electrode for the minimum time necessary in order to reduce the possibility of unintended burn injury.Using the coated electrode at a high power setting may cause damage to the coating.This is the first complaint of its kind in the last 2.8 years of complaint reviews.In the same time period, we have sold 11964 number of eaches.= low 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 informaiton pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: MCKESSON
• Common Device Name: COATED 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
• MDR Report Key: 18193886
• Report Number: 3007208013-2023-00058
• Device Sequence Number: 20781161
• Product Code: GEI
• UDI-Device Identifier: 20612479210091
• UDI-Public: 20612479210091
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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 Catalogue Number: 22-ES59T
• Device Lot Number: 0223Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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
• Patient Sex: Unknown