MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION; GENERATOR

Model Number	APYX-RS3
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported the patient received a third degree, full thickness burn from a monopolar handpiece when the device, described by the reporter as a "pencil," activated unintentionally, without prompting while resting on the patient's skin.The handpiece is reported to have unintentionally activated a second time while away from the patient and staff.The physician excised the burned tissue.The generator and monopolar handpiece were returned to apyx medical and were subject to evaluation and inspection in accordance with standard operating procedures.It was noted the renuvion system generator was purchased from an online auction site, (e.G.Ebay) and not from the manufacturer or distributor.The monopolar handpiece is not manufactured by apyx medical, bore no visible labeling or direct part marking, and resembles several commercially available products.The reported event could not be confirmed through testing and troubleshooting.The generator unit passed all testing and was found acceptable for use.The monopolar device was dismantled and assessed, but no cause of the inadvertent activation was able to be detected.The instructions for use (ifu) related to the handling of the renuvion system generator (mc-55-286-002a rev.5) cautions: "when not using active accessories, place them in a holster or in a clean, dry, non-conductive, and highly visible area not in contact with the patient.Inadvertent contact with the patient may result in burns." although the renuvion system generator passed all testing and inspection and apyx was unable to discern the manufacturer of the monopolar handpiece or replicate the reported event, the event is being reported out of an abundance of caution.
Event or Problem Description
The patient was burned by the unprompted activation of an unidentified monopolar handpiece during a procedure in which an apyx generator was used.

• Brand Name: RENUVION
• Common Device Name: 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
• MDR Report Key: 21510528
• Report Number: 3007593903-2025-00002
• Device Sequence Number: 4590962
• Product Code: GEI
• UDI-Device Identifier: 00607151050115
• UDI-Public: (01)00607151050115(11)200318
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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
• Date Returned to Manufacturer: 02/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• 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: UNIDENTIFIED MONOPOLAR HANDPIECE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female