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

Catalog Number BVX-100H

Device Problems Grounding Malfunction (1271); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problems Burn(s) (1757); Patient Problem/Medical Problem (2688)

Event Date 09/26/2018

Event Type  Injury  

Event Description

A patient suffered from a burn from a grounding pad during a surgical procedure.

• Brand Name: J-PLASMA
• Type of Device: BOVIE ULTIMATE GENERATOR
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: april woodson ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7273842323
• MDR Report Key: 8025386
• MDR Text Key: 125703834
• Report Number: 3007593903-2018-00050
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10607151009769
• UDI-Public: 10607151009769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BVX-100H
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR