MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-270B
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pneumothorax (2012); Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A (b)(6) female patient with medical history of chronic pulmonary obstructive disease (copd) secondary to smoking, underwent a renuvion procedure on (b)(6) 2022, which took place (b)(6).The surgery was performed using the apyx-270b with generator settings at 70% power and 3 liters of flow per minute under general anesthesia with oral tracheal intubation.Accumulation of helium gas during the procedure was massaged and suctioned at the end of the procedure with some improvement and the patient was discharged home.Subsequently, the patient suffered respiratory distress resulting in extensive subcutaneous emphysema (face, neck, arms, back, abdomen and thighs), marginal right pneumothorax and complete left pneumothorax diagnose by a ct-scan.The patient was admitted to a hospital intensive care unit and was treated with a chest tube to the left lung.Further review by the apyx medical advisory board determined the following: improper tunneling was performed prior to use of the renuvion handpiece.Insufficient number of portals and their interconnection to facilitate the evacuation of gases during the procedure.High gas flow configuration (3 liters per minute in all treated areas).Final aspiration was not done at the end of the procedure to evacuate the remaining helium gas in the subcutaneous space.Patients with a degree of copd, may endure a pulmonary bullae and have special ventilatory requirements.If not managed properly, may result in a pneumothorax.Even though the surgeon was fully trained by the apyx medical clinical nursing staff, the surgeon did not follow the training.The subcutaneous emphysema is a result of the surgeon not following the apyx medical training and instructions for use for ensuring proper gas egress.The pneumothorax was most likely due to inappropriate ventilation technique for an intubed copd patient during the renuvion procedure.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• 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: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760
• MDR Report Key: 14360199
• Report Number: 3007593903-2022-00001
• Device Sequence Number: 14477644
• Product Code: GEI
• UDI-Device Identifier: 00607151050016
• UDI-Public: 00607151050016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151325
• 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): 05/06/2022

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-270B
• Device Catalogue Number: APYX-270B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 48 YR
• Patient Sex: Female