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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 10CM, NITINOL; PROBE, RADIOFREQUENCY LESION
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MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 10CM, NITINOL; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number RF-NE-10
Medical Device Problem Code Smoking (1585)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant device: reusable electrode, 10cm, nitinol.The device functioned as intended during a simulated lesion test.No visual or functional anomalies were noted.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the reported smoking remains unknown.
 
Event or Problem Description
Related manufacturing ref: 3004617090-2020-00002.During device testing, the probes started smoking when testing on the grounding pad.There was no patient involved.
 
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Brand Name
REUSABLE ELECTRODE, 10CM, NITINOL
Common Device Name
PROBE, RADIOFREQUENCY LESION
Manufacturer (Section D)
MINTA MEDICAL LIMITED
caddick road
merseyside knowsley L34 9 HP
UK  L34 9HP
MDR Report Key9744198
Report Number3004617090-2020-00003
Device Sequence Number2483110
Product Code GXI
UDI-Device Identifier05415067025180
UDI-Public05415067025180
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K090608
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/24/2020
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
Operator of Device Other
Device Model NumberRF-NE-10
Device Catalogue NumberRF-NE-10
Device Lot NumberM14597
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/27/2020
Initial Report FDA Received Date02/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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