MAUDE Adverse Event Report: APYX MEDICAL CORPORATION J-PLASMA

Model Number	BVX-330B
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subsequent investigation of the returned device and extensive internal testing has ruled out this type of damage as occurring during the manufacturing or shipping processes.This issue was 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.Skin ports were used at the incision site that 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 have been 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.Note: when this incident was first reported, there were no patient injuries and based on the investigation, there was no malfunction.Due to subsequent reports of this issue occurring during clinical use in the past 30 days, it is being reported retrospectively, as it is now included as part of the field action being initiated.
Event or Problem Description
During clinical use, an unexpected stress fracture occurred on the shaft of the handpiece resulting in fragmentation.The issue was recognized by the user and the physician completed the procedure with another device.There was no injury to the patient or physician.

• Brand Name: J-PLASMA
• Common Device Name: J-PLASMA
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater, fl
• MDR Report Key: 9989962
• Report Number: 3007593903-2020-00015
• Device Sequence Number: 11911477
• Product Code: GEI
• UDI-Device Identifier: 00607151010157
• UDI-Public: 00607151010157
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: BVX-330B
• Device Catalogue Number: BVX-330B
• Device Lot Number: 0619C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2019
• Initial Report FDA Received Date: 04/23/2020
• 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: 3007593903-04/28/20-001C
• Patient Sequence Number: 1
• Patient Age: 33 YR