MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA

Model Number	J-PLASMA
Medical Device Problem Codes	Self-Activation or Keying (1557); Activation, Positioning or Separation Problem (2906); Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The reported complaint was the hand piece stayed activated when releasing the trigger.

• Brand Name: J-PLASMA
• Common Device Name: J-PLASMA
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 9238447
• Report Number: 3007593903-2019-00027
• Device Sequence Number: 16627969
• Product Code: GEI
• UDI-Device Identifier: 00607151009458
• UDI-Public: 00607151009458
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2019

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: 08/01/2022
• Device Model Number: J-PLASMA
• Device Catalogue Number: BVX-150B
• Device Lot Number: 0818J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1