MAUDE Adverse Event Report: BOVIE MEDICAL CORP MCKESSON; ELECTORSURGICAL PENCIL

Model Number	22-ESP1H
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was inspected prior to surgery, but was not documented.Customer is using a renuvion generator with serial number (b)(4) at 35/35 cut and coag.Customer used the device about 20% of surgery time.Customer confirmed that they replaced the electrode that came with the 22-esp1h with another branded electrode.Customer stated they confirmed the electrode was fully inserted.Customer stated the metal shaft was not exposed during the surgery, customer confirmed eschar was removed from the electrode as needed and there was no buildup on the electrode during surgery.This issue occurred during a breast lift procedure.Burned area of skin was removed to prevent further scarring.Another device was used to complete the surgery, however the device did not break, nor did it cause permanent injury to patient.We were made aware on 5/15/2022 that the pencil was available for return.An rma was provided.A follow up report will be submitted once we have evaluated the device.This is an isolated event.
Event or Problem Description
The customer alleged that while using a 22-esp1h with an unknown electode part number/brand, the patient received a minor burn around the entry way of the operating site during a breast lift procedure.
Additional Manufacturer Narrative
Product was received through the rma room on date 6/15/2022.Product handpiece was tested with in house generator, electrode, and grounding electrode pad and cable.Product functioned as intended, arcing to the grounding plate, confirming device passes continuity testing.Review of ethicon/megadyne website found electrode replaced from the 22-esp1h is their part number 0012m - e-z clean blade modified 2.5 inch.Complaint confirmed.It is believed the pencil-to-electrode connection area became exposed to blood/bodily fluids, causing arcing/burning at the connection site.(reference img_0533) this exposure to heat on the metal shaft may have led to a break down of insulation and potential for shock/arcing to the patient from the exposed shaft.Root cause is believed to be operator error in choosing the incorrect electrode.Based on the above information and the information provided in the intial report.No further actions are required.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.

• Brand Name: MCKESSON
• Common Device Name: ELECTORSURGICAL PENCIL
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton corp; clearwater FL 33760
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 14461874
• Report Number: 3007208013-2022-00020
• Device Sequence Number: 5050605
• Product Code: GEI
• UDI-Device Identifier: 10612479209128
• UDI-Public: 10612479209128
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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 Expiration Date: 04/20/2024
• Device Model Number: 22-ESP1H
• Device Catalogue Number: 22-ESP1H
• Device Lot Number: 210406046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown