MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 10/26/2021

Event Type  Injury  

Event Description

It was reported by distributor that a healthy female patient experienced a possible embolism post liposuction and subdermal coagulation procedure to the inner thighs on (b)(6) 2021.The generator settings were at 80% gas and 2 liters of flow.Previous procedures to the treated area include liposuction, pal (power assisted liposuction).Insertion sites were at the inner thighs.6 passes were performed, treatment plane depth was intermediate.Undermining was performed with a cannula (not specified type).During the procedure, the patient's vital signs dropped.However, within three minutes the patient's vital signs were normalized after resuscitation.An aerial embolism was suggested by the surgeon.It was noted that there are no long term health effects on the patient and the patient is currently in a healthy state.Upon verbal communications with apyx medical affairs and the customer, there was no proper gas egress, this was a technique issue and there was no embolism.The customer was not following proper protocol.Re-education will be done to prevent future occurrences.

• Brand Name: RENUVION
• Type of Device: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7273842323
• MDR Report Key: 12844920
• MDR Text Key: 283610670
• Report Number: 3007593903-2021-00029
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female