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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION J-PLASMA
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BOVIE MEDICAL CORPORATION J-PLASMA Back to Search Results
Model Number J-PLASMA
Device Problems Self-Activation or Keying (1557); Activation, Positioning or Separation Problem (2906); Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/26/2019
Event Type  malfunction  
Manufacturer Narrative
Testing of the device showed it to be working as intended.The reported complaint was not able to be replicated.
 
Event Description
The reported complaint was the hand piece immediately activated when connected to the generator without depressing the trigger.
 
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Brand Name
J-PLASMA
Type of Device
J-PLASMA
Manufacturer (Section D)
BOVIE MEDICAL CORPORATION
5115 ulmerton road
clearwater FL 33760 4004
Manufacturer Contact
april baures
5115 ulmerton road
clearwater, FL 33760-4004
7273842323
MDR Report Key9219287
MDR Text Key192451809
Report Number3007593903-2019-00026
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151325
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/22/2019
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 Health Professional
Device Expiration Date06/01/2023
Device Model NumberJ-PLASMA
Device Catalogue NumberBVX-330B
Device Lot Number0619C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2019
Initial Date Manufacturer Received 09/26/2019
Initial Date FDA Received10/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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