MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA PRECISE 33CM BLADE; BVX-330B

Model Number	BVX-330B
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint did not alleged patient injury or any adverse event.The handpiece used by the user facility have activation issues.The facility had a spare handpiece and were able to perform the procedure without any delay of treatment.Bovie have determined that the reported event did not represent a risk.Report was submitted to follow up with facility report sent to the fda report # (b)(4).
Event or Problem Description
Complaints alleged that during laparoscopic ablation procedure the j-plasma handpiece was not working properly.No patient injury resulted from the event.

• Brand Name: J-PLASMA PRECISE 33CM BLADE
• Common Device Name: BVX-330B
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 7661389
• Report Number: 3007593903-2018-00032
• Device Sequence Number: 184452
• Product Code: GEI
• UDI-Device Identifier: 10607151010154
• UDI-Public: (01)10607151010154(17)220301(10)0318K
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nursing Assistant
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: Physician
• Device Expiration Date: 03/01/2022
• Device Model Number: BVX-330B
• Device Catalogue Number: BVX-330B
• Device Lot Number: 0318K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1