MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION; BOVIE J-PLASMA HANDPIECE

Model Number	BVX-330B
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Extensive internal testing has ruled out this type of damage as occurring during the manufacturing or shipping processes.This issue is most likely caused by inadvertent damage to the distal end of the shaft caused by the user either during clinical use or while removing coagulum/eschar from the electrode.When skin ports are used at the incision site this could result in damage at the distal end of the handpiece due to the tight interference with the outer diameter of the shaft of the device.The damage seen during clinical use may also be caused by one or a combination of the following factors: (1) subjecting the device to unknown solvents, chemicals or disinfectants or any additional cleaning or reuses that may compromise essential material and design characteristics as well as the structural integrity of the device and lead to device failure, (2) use of a scratch pad (commonly available in surgical environments) or other abrasive materials to clean the blade, and/or (3) modifying or altering the tip of the device.The ifu gives cleaning instructions to avoid any type of abrasive damage "for optimum performance, keep the distal end of the shaft free of debris.A damp gauze pad can be used for cleaning" as well as instructions to avoid recleaning, resterilization or reuse.
Event or Problem Description
In (b)(6), during a cosmetic procedure, an unexpected stress fracture occurred on the shaft of the handpiece resulting in fragmentation.The issue was not recognized by the user and resulted in an additional medical intervention to remove the fragment from the patient.The patient recovered with no complications.

• Brand Name: RENUVION
• Common Device Name: BOVIE J-PLASMA HANDPIECE
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 10945649
• Report Number: 3007593903-2020-00028
• Device Sequence Number: 14294958
• Product Code: GEI
• UDI-Device Identifier: 00607151010157
• UDI-Public: 00607151010157
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 12/03/2020

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 Expiration Date: 01/01/2023
• Device Model Number: BVX-330B
• Device Catalogue Number: BVX-330B
• Device Lot Number: 0120F
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2061-2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR