MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	RENUVION/J-PLASMA SYSTEM GENERATORS (APYX HELIUM PLASMA GENERATOR)
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 60 year old very thin female patient with no medical history and no previous procedures to the treated area underwent micro-aire liposuction followed by subdermal coagulation with renuvion to the submental area.The surgeon reported a noticeable blister formation in the treatment area following 1 treatment pass of the renuvion device with generator settings of 20% power and 4 liter per minutes (lpm) of helium flow.Upon discovery of the blister, the generator settings were changed to 60% power and 1.5 lpm of helium flow, and the treatment was continued to both the right and left side of the neck.The initial generator settings of 20% and 4 lpm of the renuvion device would not have contributed to formation of a blister after one treatment pass at appropriate device treatment speeds.Continuing treatment following formation of a blister in the treatment area is not recommended.The cause of the event is unknown at this time, but continuing treatment following formation of a blister in the treatment area is not recommended.The generator will be sent back to apyx medical corporation for a full evaluation.
Event or Problem Description
This report is a follow up to 3500a report-3007593903-2022-00016.The initial report was submitted as a patient sustained a blister after micro-aire liposuction followed by subdermal coagulation with renuvion to the submental area.The performing surgeon reported a noticeable blister formation in the treatment area following one treatment pass with the renuvion device with generator settings of 20% power and 4 liter per minutes (lpm) of helium flow.Upon discovery of the blister, the generator settings were changed to 60% power and 1.5 lpm of helium flow, and the treatment was continued.The initial generator settings of 20% and 4 lpm of the renuvion device would not have contributed to formation of a blister after one treatment pass at appropriate device treatment speeds.Although the root cause of the event is unknown, continuing treatment following formation of a blister in the treatment area is not a recommended practice.Per the performing surgeon's request, the apyx medical generator was returned and a full "evaluation" was performed at apyx medical corporation.The generator was subjected to testing.No issues were found, all outputs are within specifications and passed testing.The generator functioned as intended and was found acceptable for use.No further follow up is necessary.

• 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 ulmterton road; clearwater FL 33760
• Manufacturer Contact: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760 ; 7273842323
• MDR Report Key: 15028217
• Report Number: 3007593903-2022-00016
• Device Sequence Number: 6230691
• Product Code: GEI
• UDI-Device Identifier: 00607151050115
• UDI-Public: 00607151050115
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K192867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: RENUVION/J-PLASMA SYSTEM GENERATORS (APYX HELIUM PLASMA GENERATOR)
• Device Catalogue Number: APYX-RS3
• Device Lot Number: BV2319010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICRO-AIRE LIPOSUCTION.; MICRO-AIRE LIPOSUCTION.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female