MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-330BPS
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure with renuvion, a fragment of the blade from the apyx medical device broke off inside of the patient.This event occured as the surgeon did not retract the blade prior to the subdermal coagulation as recommended by the instruction for use.C-arm (x-ray) was used to locate the tip.A fragment about a 1-2mm was found over the patient's left scapula area.The surgeon attempted to remove the fragment with various techniques but was not successful.The broken tip was unable to be removed and the procedure was completed with new handpiece.However, the patient is doing well.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 12515256
• Report Number: 3007593903-2021-00017
• Device Sequence Number: 14738980
• Product Code: GEI
• UDI-Device Identifier: 00607151050078
• UDI-Public: 00607151050078
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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: No Information
• Device Model Number: APYX-330BPS
• Device Catalogue Number: APYX-330BPS
• Device Lot Number: 0721J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/22/2021
• 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