MAUDE Adverse Event Report: APYX MEDICAL CORPORATION APYX ONE CONSOLE; ELECTROSURGICAL GENERATOR

Model Number	APYX-ONE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A female patient experienced a burn to their neck in which renuvion was used as part of the overall surgical procedure.
Additional Manufacturer Narrative
The patient received a 2rd degree burn on her neck.Temporary and/or permanent injury as a result of a burn is a known potential complication for this technology and treatment.

• Brand Name: APYX ONE CONSOLE
• Common Device Name: ELECTROSURGICAL GENERATOR
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: graham cuthbert ; 5115 ulmerton road; clearwater, FL 33760
• MDR Report Key: 18260506
• Report Number: 3007593903-2023-00011
• Device Sequence Number: 20751161
• Product Code: GEI
• UDI-Device Identifier: 00607151050221
• UDI-Public: 00607151050221
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: APYX-ONE
• Device Catalogue Number: APYX-ONE
• Device Lot Number: 37441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female