MAUDE Adverse Event Report: BOVIE MEDICAL BOVIE; GROUNDING PAD

Model Number	A802EU
Health Effect - Clinical Codes	Electric Shock (2554); Superficial (First Degree) Burn (2685)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that while using the a952 with the a802eu, the physician is receiving shocks of electricity and the patient is receiving slight burning/pain in their eyes.There was no significant damage to the user or the patient.
Additional Manufacturer Narrative
The customer was contacted with questions regarding the incident on (b)(6) 2022 customer was unwilling to cooperate answering questions about the incident and claimed he had been operating in electrosurgery for over 30 years.Symmetry sales representative went in person to give a demo of how to properly ground patients using the grounding plate.During their review, it was found that the physician was getting shocked during use by using non-insulated forceps without gloves on in combination with the electrosurgical pencil.It was unable to be determined through discussion with the customer if the event of eye pain was related to use of electrosurgery equipment.Per request of the customer and to ensure there are no faults of the generator, the a942 generator was sent in for repair.This is the only complaint recorded with (b)(4)sold of all lots.A follow up report will be submitted once the a942 is evaluated by the repair facility.
Additional Manufacturer Narrative
Per the request of the customer, the users a942 generator was sent to our repair facility for evaluation to confirm that there were no faults in the generator.The device was evaluated and confirmed that the generator and the a902 handpiece were operating according to specification.The complaint was confirmed through investigation with the end user for shocking the physician.Root cause was determined to be user error in setup of generator/ non-insulated forceps.The complaint was not able to be confirmed for patient sensation in the eyes.The root cause is unable to be determined for this scenario without further information from the end user.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: GROUNDING PAD
• Manufacturer (Section D): BOVIE MEDICAL; 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: 13536380
• Report Number: 3007208013-2022-00002
• Device Sequence Number: 4910763
• Product Code: GEI
• UDI-Device Identifier: 10607151001534
• UDI-Public: 10607151001534
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K955681
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 02/16/2025
• Device Model Number: A802EU
• Device Catalogue Number: A802EU
• Device Lot Number: 2021-02-16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown