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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 10CM, SST; PROBE, RADIOFREQUENCY LESION
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MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 10CM, SST; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number RF-SE-10
Device Problem Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2018
Event Type  Injury  
Event Description
Related manufacturer report number: 3004617090-2018-00010, 3002953813-2018-00091.During a bi-polar ablation procedure, the probes connected to ports 1 and 2 did not reach temperature and one of the probes melted.The probes were replaced, the generator was power cycled, and the outlet changed, but the temperature issue remained.The procedure was cancelled, but there were no adverse patient consequences.
 
Manufacturer Narrative
Additional information: the reported temperature issue could not be confirmed.The device functioned as intended during a simulated lesion test.No functional anomalies were noted.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the temperature issue remains unknown.
 
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Brand Name
REUSABLE ELECTRODE, 10CM, SST
Type of Device
PROBE, RADIOFREQUENCY LESION
Manufacturer (Section D)
MINTA MEDICAL LIMITED
caddick road
merseyside knowsley L34 9 HP
UK  L34 9HP
MDR Report Key8148763
MDR Text Key129880628
Report Number3004617090-2018-00011
Device Sequence Number1
Product Code GXI
UDI-Device Identifier05415067025227
UDI-Public05415067025227
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,health
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberRF-SE-10
Device Lot NumberM13607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2018
Was the Report Sent to FDA? No
Date Manufacturer Received12/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NEUROTHERM RF ELECTRODE; NEUROTHERM RF GENERATOR
Patient Outcome(s) Other;
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