MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA PRECISE 360; BVX-330BR

Model Number	BVX-330BR
Medical Device Problem Codes	Detachment Of Device Component (1104); Use of Device Problem (1670); Human Factors Issue (2948)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reported complaint alleged that the peek tip of the handpiece fell off during a laparoscopic robotic procedure.

• Brand Name: J-PLASMA PRECISE 360
• Common Device Name: BVX-330BR
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 7583668
• Report Number: 3007593903-2018-00028
• Device Sequence Number: 1988346
• Product Code: GEI
• UDI-Device Identifier: 10607151010727
• UDI-Public: (01)10607151010727(17)210201(10)0217F
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K152570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2018

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: 02/07/2017
• Device Model Number: BVX-330BR
• Device Catalogue Number: BVX-330BR
• Device Lot Number: 0217F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• 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: 06/08/2018
• Patient Sequence Number: 1