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	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial investigation concluded that the reported complaint was an isolated event.Based on the investigation completed by engineering, user interview, sample evaluation and the manufacturing documentation reviewed, the root cause of the event can be attributed to a human factor.Surgeon acknowledged that he applied excessive force to the device while removing from the cannula/trocar.Engineering testing was able to replicate the event and confirmed that the failure mode observed in the return handpiece and the sample used to replicate the event were similar.In addition, samples from the same sterile lot were pull tested to ensure that the units were within specification.Test results found that all samples were found within specifications.On 05/11/2018 a second complaint was reported.Therefore, bovie determined on 06-05-2018 to reopen this complaint for further evaluation.Investigation concluded that even though there was no patient injury in the reported complaints and that the complaint is isolated to one end user, the reoccurrence of the event can result in harm.
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: 7583654
• Report Number: 3007593903-2018-00027
• Device Sequence Number: 2501475
• Product Code: GEI
• UDI-Device Identifier: 10607151010727
• UDI-Public: (01)10607151010727(17)210301(10)0317B
• 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: company representative,health
• 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: 03/01/2021
• Device Model Number: BVX-330BR
• Device Catalogue Number: BVX-330BR
• Device Lot Number: 0317B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1