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

Model Number	APYX-15-TP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was infiltrated around 150 ml and undermined with 3.0 mm cannula.The generator settings for the apyx handpiece were 60% power with a 1.0 lpm helium flow rate.The doctor states he used retrograde passes with the handpiece at 2 -3 cm per minute at a superficial or deep plane depth.The patient sustained a deep partial-thickness (second-degree) burn which progressed into a full-thickness (third-degree) burn with necrotic tissue.Patient is undergoing conservative treatment with ointment.Apyx's clinical operations manager performed an inservice with the doctor after the reported injury.The clinical operations manager noted inconsistencies in the doctor's technique, particularly with the motion and quantity of strokes, as well as the generator settings with what is outlined in the company's user training and subdermal coagulation technique considerations.After presenting their observations of high settings, repetitive strokes, and crosshatching to the doctor, both the doctor and the clinical operations manager suggested/believed technique as the most probable cause of the event.The device was discarded and not available for evaluation.Temporary and/or permanent injury as a result of a burn is a known potential complication for this technology and treatment.
Event or Problem Description
The patient sustained a deep partial-thickness (second-degree) burn which progressed into a full-thickness (third-degree) burn on their neck after a procedure in which renuvion was used as part of the overall surgical treatment.

• Brand Name: RENUVION APR HANDPIECE
• Common Device Name: ELECTROSURGICAL HANDPIECE
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater 33760
• Manufacturer (Section G): APYX MEDICAL INC; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: graham cuthbert ; 5115 ulmerton road; clearwater 33760 ; 7278038503
• MDR Report Key: 19292107
• Report Number: 3007593903-2024-00004
• Device Sequence Number: 7339392
• Product Code: GEI
• UDI-Device Identifier: 00607151050153
• UDI-Public: 00607151050153
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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-15-TP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 64 YR
• Patient Sex: Female