MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; RETURN PAD

Model Number	ESRSC
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that while using the esrs the patient received mild burns at the application site of the return electrode pads.There are no specific details availble as it was report a few days post surgery.
Additional Manufacturer Narrative
Customer alleges that there were four separate but similar events when using the esrs pad with a1252c cable.Please reference mdr reports 3007208013-2022-000013 - 3007208013-2022-000016.Common characteristics of the complaint received from customer: customer inspected products before use, but no documentation was created for the inspection customers were using a2350 generators with serial numbers (b)(4) while using esp1 handpiece.Customer did not document the times of activations of the handpiece.Customer reported they were following the location of application of the grounding pad per the ifu.Customer stated there was no buildup of escar on the device.Burns only occurred at the sight of the grounding pad.Patient was not wearing any jewelry or lotions.Patients were above the minimum operating weight per the ifu ( 25lbs or greater) site of grounding pad was shaved, cleaned, and dried before application.Patients were administered tiva (total intravenous anaesthesia) during procedure, so pain was not able to be noticed by the patient.Customer stated the patient was not moved during the procedures and the pad was not checked during surgery.Customer was unable to take pictures of the burn sites due to ethics of their region.Customer states burns were of the first degree.Customer states the burns will not create a disability of permanent damage.Root cause is determined to be a user error in not selecting the split disposable pads for procedures per ifu.According to mc- 55-232-001 revision 3 page 11 of the a2350 generator, potential for alternate site burns increases if the return electrode is compromised.Bovie medical corporation recommends the use of split return electrodes and bovie® generators with a contact quality monitoring system.The complaint rate for this occurrence is (b)(4).Based on the above information, this can be seen as the final report.If additional informaiton is obtained that alleges any additional patient involvement a follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: RETURN PAD
• 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: 14280078
• Report Number: 3007208013-2022-00014
• Device Sequence Number: 20317142
• Product Code: GEI
• UDI-Device Identifier: 00607151001674
• UDI-Public: 00607151001674
• Combination Product (Y/N): N
• Initial Reporter Country: MP
• PMA/510(K) Number: K092761
• 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): 05/03/2022

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: 02/05/2023
• Device Model Number: ESRSC
• Device Catalogue Number: ESRS
• Device Lot Number: 2020-02-05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• 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