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

Model Number	APYX-270BPP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treatment plan included liposuction of the patient's back before renuvion.The subdermal renuvion portion of the procedure was performed using the renuvion precise handpiece (hp) which includes an extendable and retractable electrode.During the procedure, the distal nose cone of the hp handle developed a split which allowed the shaft of the hp to shift position and expose the electrode.The surgeon noticed the damage to the hp and continued to use the damaged hp during the procedure.This caused breakage of the exposed electrode.The portion of the electrode distal to the break remained in the patient.The patient is doing well and stable.There are no adverse effects on the patient's long-term health; however, once the patient's swelling has subsided, the doctor intends to remove the fragment using ultrasound mapping.The device settings were 80% power and 4.0 lpm of helium flow.The doctor reported doing 8 retrograde passes 2 cm apart at an intermediate treatment depth.The manufacturer's surgical system standards state that when performing retrograde only passes, to use 3 -5 passes per area.The instructions for use (ifu) for the precise handpiece was reviewed as part of the investigation, and it states not to use the hp if there is any damage or breakage to the hp.A review of the device history record for the manufacturing lot provides assurance that the device was manufactured to specification.The returned hp was subject to investigation in accordance with company procedures.The engineering evaluation confirmed the nose cone and a slider used to extend the blade are broken.The electrode retraction mechanism is non-functional as a result and is stuck in the extended position.
Event or Problem Description
The tip of a handpiece broke intraoperatively and remained 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: 23733249
• Report Number: 3007593903-2025-00008
• Device Sequence Number: 9743030
• Product Code: GEI
• UDI-Device Identifier: 00607151050061
• UDI-Public: (01)00607151050061(10)0000053091(11)250113(17)280101
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K183610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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-270BPP
• Device Catalogue Number: APYX-270BPP
• Device Lot Number: 0000053091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female