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

Model Number APYX-27-TP

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 02/09/2024

Event Type  Injury  

Manufacturer Narrative

Patient underwent liposuction using the microaire power assisted liposuction (pal) system and tumescent local anesthesia with approximately 400cc infusion in each thigh.300cc of fat was aspirated for each inner thigh with a 4mm cannula following treatment with renuvion.The generator settings for the apyx handpiece were 60% power with a 1.5 lpm helium flow rate.The doctor describes the handpiece passes as steady and slow at an intermediate or deeper plane depth with at least 1 cm between each pass.At the conclusion of the procedure, the doctor states that both thighs were checked and there was no heat generated from the procedure after the renuvion treatment was done.The patient was placed in a compression garment postoperativly for 1 week prior to being seen again by the doctor.At the follow-up visit the patient reported tenderness on their right inner thigh (approx.5 x 8 cm).The doctor determined this to be a second degree burn and it was debrided at the bedside.The patient was treated with local wound care including silvadene cream and was seen several times in the office for local wound care.The burn progressed to a third degree burn which was treated with surgical debridement and continued local wound care until the wound appeared to have clean granulation tissue.The patient subsequently underwent a full-thickness skin graft which appears to be healing.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 Description

The patient sustained a deep partial-thickness (second-degree) burn which progressed into a full-thickness (third-degree) burn on their right inner thigh after microaire power assisted liposuction (pal) was performed and in which renuvion was used as part of the overall surgical procedure.

• Brand Name: RENUVION APR HANDPIECE
• Type of Device: ELECTROSURGICAL HANDPIECE
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater 33760
• Manufacturer (Section G): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater 33760
• Manufacturer Contact: graham cuthbert ; 5115 ulmerton road; clearwater 33760 ; 7278038554
• MDR Report Key: 19008336
• MDR Text Key: 338955093
• Report Number: 3007593903-2024-00003
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APYX-27-TP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MICROAIRE POWER ASSISTED LIPOSUCTION (PAL)
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female
• Patient Race: White