MAUDE Adverse Event Report: BOVIE MEDICAL J-PLASMA; ELECTROSURGICAL, CUTTING, COAGULATION

Model Number BVX-330B

Device Problems Device Inoperable (1663); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

Event Type  malfunction  

Event Description

During use the j-plasma laparoscopic device malfunctioned inside the patient.It would cauterize only when the needle point was out.It would not fire properly.Company rep notified.No harm caused to patient.Device has been returned to the rep.The hospital was able to obtain another hand piece from the rep which worked.

• Brand Name: J-PLASMA
• Type of Device: ELECTROSURGICAL, CUTTING, COAGULATION
• Manufacturer (Section D): BOVIE MEDICAL; 5115 ulmerton road; clearwater FL 33760
• MDR Report Key: 7629138
• MDR Text Key: 112023688
• Report Number: 7629138
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2018

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
• Device Operator: Unknown
• Device Model Number: BVX-330B
• Device Catalogue Number: BVX-330B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 84