MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA; BOVIE ULTIMATE GENERATOR

Catalog Number	BVX-100H
Medical Device Problem Codes	Grounding Malfunction (1271); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Burn(s) (1757); Patient Problem/Medical Problem (2688)
Date of Event	09/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient suffered from a burn from a grounding pad during a surgical procedure.

• Brand Name: J-PLASMA
• Common Device Name: BOVIE ULTIMATE GENERATOR
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 8025386
• Report Number: 3007593903-2018-00050
• Device Sequence Number: 1030078
• Product Code: GEI
• UDI-Device Identifier: 10607151009769
• UDI-Public: 10607151009769
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BVX-100H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/31/2018
• 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: 24 YR