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

Model Number	BVX-270B
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A photograph of the blade that was removed from the patient was provided for investigation and revealed that the bottom edge of the blade had an uneven and jagged appearance.This would indicate the blade had been bent or manipulated in such a manner that resulted in a complete break.The break did not occur at the weld.A break at the weld would appear as a straight even line at the bottom edge of the blade and indicate a manufacturing issue as that would be the most likely spot for a break if it was manufacturing related.As the blade broke elsewhere, it is most likely due to excessive force against the blade (mishandling).
Event or Problem Description
In (b)(6), it was reported during the procedure a part of the stainless steel blade snapped off close to the insertion site and went unnoticed by the user.The patient returned to the clinic "a couple days later" with complaints of discomfort to a specific area of the left thigh which visually demonstrated a "point" (raised lump).The piece of blade just under the skin and was removed via a small incision without reported complication.There was no infection and no further issues.

• Brand Name: RENUVION/J-PLASMA
• Common Device Name: BOVIE J-PLASMA HANDPIECE
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 10946013
• Report Number: 3007593903-2020-00027
• Device Sequence Number: 14294959
• Product Code: GEI
• UDI-Device Identifier: 00607151009458
• UDI-Public: 00607151009458
• 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
• 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: 12/01/2022
• Device Model Number: BVX-270B
• Device Catalogue Number: BVX-270B
• Device Lot Number: 1219F
• Was Device Available for Evaluation?: No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR