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

Catalog Number	22-ESP6H
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer "alleged" that when using a 22-esp6h with a replaced electrode during a breast reduction, the patient received burns from sparks coming from where the tip meets the handpiece.There was no additional patient harm.
Additional Manufacturer Narrative
Product was purchased on order number (b)(4) on (b)(6) 2023 and shipped to mckesson dc 61 in la under invoice number (b)(4) on 6/6/2023 line 24.Product was sold to the end customer shortly after.Customer stated they had instances of where the patient is being burnt at the tip/pencil connection area.Customer confirmed they are replacing the original electrode that comes with the pencil, for either a e1455-6 covdien edge extended tip or 0012am megadyne guarded tip.Customer was asked questions on 10/30/2023.Customer stated: inspection was completed prior to surgery, but was not documented.Power settings were at 40/40 with pure/fulgurate mode selected.It was not known how long the pencil was held active at the times of the event.Sparking only occurred at the junction of the electrode to the pencil.Surgery was a breast reduction and no pictures of the burn site are available.No used product was available for review.New product was requested to be returned for further investigation on 10/31/2023 new product was returned through the rma room on 11/13/2023.This is the second complaint of its kinds on (b)(4) eaches of 22-esp6h in the last 2.8 years of complaint reviews.In the same time, we have sold (b)(4) number of eaches.(b)(4).The investigation for the complaint is still ongoing.A supplemental report will be submitted once we have completed the investigation or if additional pertinent information becomes available.
Additional Manufacturer Narrative
Clinical team was able to confirm user power settings are acceptable.Testing of the returned devices with the customer electrodes confirmed that the competitor electrodes fit perfectly in the 22-esp6h device, removing a fit error from being the root cause.Used product was not returned for testing or further evaluation complaint was able to be confirmed, but true root cause is unable to be determined with accuracy.It may be possible that the insertion area became wet or debris-ed when switching the electrodes during use.The complaint could not be confirmed 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: ELECTROSURGICAL PENCIL
• 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 dr; antioch, TN 37013
• MDR Report Key: 18193885
• Report Number: 3007208013-2023-00056
• Device Sequence Number: 7790704
• Product Code: GEI
• UDI-Device Identifier: 20612479209194
• UDI-Public: 20612479209194
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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 Expiration Date: 05/12/2025
• Device Catalogue Number: 22-ESP6H
• Device Lot Number: 220406205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown