MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA; J-PLASMA HAND PIECE

Catalog Number	BVX-150-BPP
Medical Device Problem Codes	Backflow (1064); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The company has completed an investigation and identified a design related issue for the interface of the j-plasma handpieces with the j-plasma generators.This design issue allows for generator and handpiece activation during a situation when the handpiece plug is not fully plugged in or connected to the generator.If the handpiece plug is not fully connected to the generator, there is a risk of the handpiece being fully connected electrically while having a partial or no helium connection.It is also possible for the green light on the front of the generator that indicates when the plug is fully connected to become illuminated even when the plug is not fully connected.Therefore, the users can be given a false indication by the generator that the handpiece is fully connected.The lack of a complete helium seal at the cable plug connection to the generator can allow fluid encountered at the tip of the handpiece during a procedure to flow from the tip to the interface between the handpiece plug and the generator.The presence of organic substances was recognized by the user and the generator was taken out of service and returned to the manufacturer.A health hazard evaluation was completed on february 5, 2018 concluded that there is a risk of potential crosscontamination if this is not noticed and the generator is used again for subsequent patients.The company previously issued a voluntary urgent medical device correction (recall) on february 8, 2018 to notify all customers of this potential issue and provided instructions on actions to prevent this from occurring (b)(4)).All devices sold since the recall was initiated have included inserts on how to properly insert the handpiece into generator.
Event or Problem Description
Generator was contaminated with biological substance from the hand piece during a j-plasma procedure.

• Brand Name: J-PLASMA
• Common Device Name: J-PLASMA HAND PIECE
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 8784310
• Report Number: 3007593903-2019-00015
• Device Sequence Number: 13952904
• Product Code: GEI
• UDI-Device Identifier: 00607151011925
• UDI-Public: 00607151011925
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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: 10/01/2020
• Device Catalogue Number: BVX-150-BPP
• Device Lot Number: 0419M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2018
• Initial Report FDA Received Date: 07/12/2019
• 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-1153-2018
• Patient Sequence Number: 1