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

Model Number	APYX-15-TP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the procedure, the apyx medical clinal support specialist suggested adding a thin layer of infiltration, but the doctor stated it is not necessary because the liposuction was brief.The arm was treated circumferentially in 360 degrees, performing 3 antegrade / retrograde (ar) passes, with some areas overlapped creating 6 ar passes.This is not in compliance with apyx medical's subdermal coagulation technique considerations (sctc), safe and effective use guidelines.The sctc states 2-3 passes with the a/r technique, and 3-6 passes with retrograde only technique.The inner portion of the patient's arm was treated by the head nurse under the observation of the doctor.The apyx medical clinal support specialist inquired regarding the legality of the nurse performing the procedure and if there was a position of a nurse practitioner nurse in belgium, but was informed no.The apyx medical clinal support specialist had to correct the nurse's speed during some strokes because she was going too slowly.After the second ar pass, both the doctor and the nurse commented that they felt the treated area (left inner arm) was very hot compared to the previously treated areas.At that point in time, the patient's skin was intact.The apyx medical clinal support specialist recommended stopping, but the doctor decided to do the final ar pass.After the gas management process a blister was identified, which turned out to be a burn.The burn was treated with flammazine 1% cream.There was no burn classification (first-degree, superficial second-degree, deep partial-thickness second-degree, or third-degree) provided by the doctor.The apyx medical clinal support specialist contacted the clinic several times to follow the status of the patient's burn.On april 26th 2024 the nurse followed-up with the apyx medical clinal support specialist stating that the wound is healing, but not in a way that won't leave a mark.
Event or Problem Description
The patient sustained a burn on their arm after a subdermal coagulation 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 FL 33760
• Manufacturer (Section G): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: graham cuthbert ; 5115 ulmerton road; clearwater, FL 33760 ; 7278038503
• MDR Report Key: 19353719
• Report Number: 3007593903-2024-00005
• Device Sequence Number: 7466577
• 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): 05/20/2024

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
• Device Catalogue Number: APYX-15-TP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/20/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EUROMI - VIBROLIO CONTROL.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 64 KG