MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA HANDPIECE; BVX-150B

Model Number	BVX-150B
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported was not attributable to a device malfunction.The doctor alleged that he started to use the returned electrode pad along with the electrosurgical unit and j-plasma handpiece and noted that the patient experienced a burn in the incision site during a subdermal procedure.The engineering team completed an investigation to determine if there are differences between rf current delivered and tissue temperatures achieved with and without a return electrode connected to the patient when a j-plasma handpiece is used in conjunction with the generator.This investigation concluded that the addition of a return electrode to unit had no impact on the amount of rf current being delivered to the patient.Rf current was comparable for all points measured with or without a return electrode connection.No noticeable increase in rf current was observed by the introduction of a grounding pad to the patient during j-plasma procedure vs no grounding pad being used.It is concluded that the addition of the return electrode had no impact on the average and maximum tissue temperature measurements.
Event or Problem Description
Complaint alleged that the patient received a burn in the incision sites right and left lower abdominal area and belly button after a j-plasma procedure.

• Brand Name: J-PLASMA HANDPIECE
• Common Device Name: BVX-150B
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 7716415
• Report Number: 3007593903-2018-00035
• Device Sequence Number: 1120758
• Product Code: GEI
• UDI-Device Identifier: 10607151010147
• UDI-Public: (01)10607151010147(17)22050(10)0518B
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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: 05/01/2022
• Device Model Number: BVX-150B
• Device Catalogue Number: BVX-150B
• Device Lot Number: 2018-05-04
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR