MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA

Model Number	BVX-270B
Medical Device Problem Codes	Self-Activation or Keying (1557); Activation, Positioning or Separation Problem (2906); Activation Problem (4042)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned as requested, so the reported complaint was unable to be thoroughly investigated and independently verified by the company.
Event or Problem Description
The reported complaint was the hand piece could activate without depressing the trigger.

• Brand Name: J-PLASMA
• Common Device Name: J-PLASMA
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater, fl
• MDR Report Key: 9793832
• Report Number: 3007593903-2020-00007
• Device Sequence Number: 11481707
• Product Code: GEI
• UDI-Device Identifier: 00607151009458
• UDI-Public: 00607151009458
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K112233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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 Model Number: BVX-270B
• Device Catalogue Number: BVX-270B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1