MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-270BPP
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to apyx medical corporation that a plastic and reconstructive surgeon with many years of experience, was performing a 360° liposuction of the abdomen flank and inferior back, utilizing a power assisted liposuction system [ s.A.F.E technique] followed by renuvion sub dermal skin tightening using a apyx-270-bpp cm apyx medical handpiece.During the second pass and before the third pass while performing the renuvion treatment, as the surgeon was introducing the handpiece, his thumb slipped on the button that releases the stainless steel blade from the handpiece and when he pulled out the handpiece the blade had become lodged inside the patient's right flank.To date, no images have been performed and the patient is aware of the retained blade.The breakage is potentially from handling/technique.However, the procedure was completed with a new handpiece and the patient is doing well with no issues.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 12681041
• Report Number: 3007593903-2021-00018
• Device Sequence Number: 1364262
• Product Code: GEI
• UDI-Device Identifier: 00607151050061
• UDI-Public: 00607151050061
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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-270BPP
• Device Catalogue Number: APYX-270BPP
• Device Lot Number: 1120F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other