MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number RENUVION APR HANDPIECE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Dyspnea (1816); Hypoventilation (1916); Low Oxygen Saturation (2477); Weight Changes (2607)

Event Date 07/18/2019

Event Type  Injury  

Event Description

Patient description: 46-year-old female patient who presented to our office requesting high definition liposculpture.Past medical history remarkable for a previous liposuction (6 years ago) in addition to breast augmentation with implants and umbilical hernia repair.No complications were reported in these procedures.Non other relevant data.Physical examination showed a patient with skin adhesions in the middle abdomen and loosening of the lower abdominal region and fat pad accumulation related to weight gain.Procedure: high definition liposculpture plus renuvion® therapy applied to the abdomen and flanks in addition to mini-abdominoplasty and a 1-cm umbilical hernia repair with primary closure.Breast lift surgery with implant replacement was also performed.Post-operative period: patient started complaining of shortness of breath within the first 24 hours after surgery.Pulse oximetry was 85% (fio2: 21%) and bi-basal hypoventilation was reported on physical exam.A chest x-ray and ct scan were performed and results showed pneumoperitoneum.The patient underwent a diagnostic laparoscopy that ruled out damage of the abdominal structures or visceral perforation.The patient remained hospitalized under medical observation and was discharged after 2 days without major complications.This patient 12-month follow up included an abdominal x-ray and physical examination during the appointment.

• Brand Name: RENUVION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 16043174
• MDR Text Key: 306207219
• Report Number: MW5113967
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2022

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
• Device Operator: Health Professional
• Device Model Number: RENUVION APR HANDPIECE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White