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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 10CM, NITINOL CE; PROBE, RADIOFREQUENCY LESION
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MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 10CM, NITINOL CE; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number RF-NE-10-CE
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2018
Event Type  Injury  
Event Description
Related manufacturing ref: 3004617090-2018-00013, 3004617090-2018-00014.During the procedure, three electrodes displayed a no thermocouple error and the procedure was cancelled.There were no adverse consequences to the patent due to the cancellation.
 
Manufacturer Narrative
Additional information: the reported error message was confirmed.An error message was noted on the generator when the electrode was connected and no temperature was displayed.Electrical testing revealed high, variable resistance between the thermocouple wires, consistent with the error message displayed.The source of the high resistance was isolated to within the hub and tubing assembly.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the high and variable resistance and subsequent procedure cancellation remains unknown.
 
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Brand Name
REUSABLE ELECTRODE, 10CM, NITINOL CE
Type of Device
PROBE, RADIOFREQUENCY LESION
Manufacturer (Section D)
MINTA MEDICAL LIMITED
caddick road
merseyside knowsley L34 9 HP
UK  L34 9HP
MDR Report Key8189247
MDR Text Key131147244
Report Number3004617090-2018-00012
Device Sequence Number1
Product Code GXI
Combination Product (y/n)N
PMA/PMN Number
K090608
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberRF-NE-10-CE
Device Lot NumberM12931
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2019
Was the Report Sent to FDA? No
Date Manufacturer Received01/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
REUSABLE ELECTRODE; REUSABLE ELECTRODE; REUSABLE ELECTRODE; REUSABLE ELECTRODE
Patient Outcome(s) Other;
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