• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOVIE MEDICAL J-PLASMA; ELECTROSURGICAL, CUTTING, COAGULATION Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
J-PLASMA
Type of Device
ELECTROSURGICAL, CUTTING, COAGULATION
Manufacturer (Section D)
BOVIE MEDICAL
5115 ulmerton road
clearwater FL 33760
MDR Report Key7629138
MDR Text Key112023688
Report Number7629138
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberBVX-330B
Device Catalogue NumberBVX-330B
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/14/2018
Event Location Hospital
Date Report to Manufacturer06/14/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age29 YR
Patient Weight84
-
-