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	Burn(s) (1757)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient underwent microaire power assisted liposuction (pal) followed by renuvion treatment in the neck and submental area.The renuvion device settings were 80% power with a 1.5 lpm helium flow rate and a total of 6.0 kilojoules (kj) delivered.The doctor states he used 3 slow speed retrograde passes at an intermediate plane depth with treatment strokes performed at 0.5 cm apart from each other.A size 2 medical z compression garment was applied post procedure.Two weeks post-operatively the patient came to the office for suture removal and presented with the burn.The patient was treated with hyperbaric oxygen, antibiotic ointments, and exosomes for the wound.Apyx medical's subdermal coagulation technique considerations (sctc) recommends treatment strokes be performed 2 - 3 cm apart.Performing the treatment strokes closer together than recommended may have contributed to the injury.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 presented with a burn on their neck / chin / submental area 2 weeks 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 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: 19920015
• Report Number: 3007593903-2024-00007
• Device Sequence Number: 7218713
• Product Code: GEI
• UDI-Device Identifier: 00607151050153
• UDI-Public: (01)00607151050153(10)0000024311(17)250601
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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 Expiration Date: 06/01/2025
• Device Model Number: APYX-15-TP
• Device Catalogue Number: APYX-15-TP
• Device Lot Number: 0000024311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2022
• 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: MICROAIRE POWER ASSISTED LIPOSUCTION (PAL)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 64 KG