MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION; ELECTROSURGICAL GENERATOR

Model Number	APYX-RS3
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Pneumothorax (2012); Low Oxygen Saturation (2477)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient appeared to experience subcutaneous emphysema with drop in peripheral oxygen saturation during a procedure in which renuvion was used as part of the overall surgical treatment.The patient appeared to experience subcutaneous emphysema with drop in peripheral oxygen saturation during a procedure in which renuvion was used as part of the overall surgical treatment.
Additional Manufacturer Narrative
The treatment plan included skin tightening to the upper arms.Patient was infiltrated with tumescence and after approximately 30 minutes two insertion sites were made on the shoulder and two were made in the elbow for gas egress.The renuvion device settings were 70% power and 1.5lpm of helium flow.Approximately 10 minutes into treatment the patient complained of pain in the neck and chest.Treatment was stopped.The patient's chest had been covered by a sterile drape preventing the surgical staff from observing any buildup of tension in the body.Subcutaneous emphysema was detected in the face, neck and trunk.Evacuation of the gas towards the arms was followed by a decline in oxygen saturation.The patient was admitted to the nearest hospital with a diagnosis of pneumothorax.A chest tube was inserted, and the patient was monitored during reduction of the emphysema.The patient was discharged home in good condition after three days.The surgeon noted in the future they need to ensure pretunnling is interconnected thoroughly, monitor the trunk for gas accumulation and sufficient insertion sites are utilized to allow for gas egress.Additionally, the surgeon stated that perhaps massaging out the emphysema led to the pneumothorax.As with all energy devices there are inherent risks associated with the use of renuvion.Risks included in the instructions for use are: pneumothorax, temporary or permanent nerve injury, ischemia, pain, discomfort, gas buildup resulting in temporary and transient crepitus or pain.

• Brand Name: RENUVION
• Common Device Name: ELECTROSURGICAL GENERATOR
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer (Section G): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: graham cuthbert ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7278038503
• MDR Report Key: 22162119
• Report Number: 3007593903-2025-00006
• Device Sequence Number: 8842390
• Product Code: GEI
• UDI-Device Identifier: 00607151050115
• UDI-Public: (01)00607151050115(11)230620
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192867
• 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,Followup
• Report Date (Section B): 09/15/2025

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-RS3
• Device Catalogue Number: APYX-RS3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female