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

Model Number	APYX-15-TP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Full thickness (Third Degree) Burn (2696)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treatment plan included bilateral augmentation mammoplasty, mini abdominoplasty, renuvion use on the anterior abdomen, buttocks and circumferential thighs, and bellafill to the hands and temple.The renuvion device settings were 100% power and 1.5 lpm of helium flow with 8 antegrade/retrograde passes, these settings are outside of the recommended settings in the instructions for use.The doctor reported that during the treatment along the distal, medial thigh the burn was sustained subsequent to the tip of the device becoming dislodged / broken.An attempt to retrieve the device fragment using a hemostat was performed without success.The doctor states the patient's current condition is good.The device has not yet been returned for evaluation.As with all energy devices there are inherent risks associated with the use of renuvion.Risks included in the instructions for use are: unintended burns (deep or superficial), ischemia, fibrosis, infection, pain, discomfort, pigmentation changes, increased healing time, unsatisfactory scarring, asymmetry and/or unacceptable cosmetic result.
Event or Problem Description
The patient received a full thickness burn on the medial, distal thigh and a segment of the handpiece is believed to have become dislodged and was retained in the patient during a procedure in which renuvion was used as part of the overall surgical treatment.

• Brand Name: RENUVION
• Common Device Name: ELECTROSURGICAL HANDPIECE
• 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: 21913515
• Report Number: 3007593903-2025-00004
• Device Sequence Number: 20642480
• Product Code: GEI
• UDI-Device Identifier: 00607151050153
• UDI-Public: (01)00607151050153(10)0000051395(11)241017(17)271001
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K230272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: APYX-15-TP
• Device Catalogue Number: APYX-15-TP
• Device Lot Number: 0000051395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• 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: Other
• Patient Age: 59 YR
• Patient Sex: Female