MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA

Model Number BVX-270B

Device Problems Self-Activation or Keying (1557); Activation, Positioning or Separation Problem (2906); Activation Problem (4042)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 02/10/2020

Event Type  malfunction  

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 Description

The reported complaint was the hand piece could activate without depressing the trigger.

• Brand Name: J-PLASMA
• Type of Device: J-PLASMA
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater, fl
• Manufacturer Contact: april baures ; 5115 ulmerton road; clearwater, fl ; 3842323855
• MDR Report Key: 9793832
• MDR Text Key: 192451338
• Report Number: 3007593903-2020-00007
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607151009458
• UDI-Public: 00607151009458
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K112233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BVX-270B
• Device Catalogue Number: BVX-270B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1