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	10/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A female patient experienced a burn after power assisted liposuction (pal) was performed to their arm and in which renuvion was used as part of the overall surgical procedure.
Additional Manufacturer Narrative
The patient received a 3rd degree burn on her arm.Temporary and/or permanent injury as a result of a burn is a known potential complication for this technology and treatment.Attempts to gather additional information from the doctor were not successful.

• 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: 18159858
• Report Number: 3007593903-2023-00010
• Device Sequence Number: 6449080
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2023

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: 35944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROAIRE POWER-ASSISTED LIPOSUCTION (PAL)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female