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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP COOL-TIP RF SINGLE ELECTRODE KIT 10CM X 3CM; COOL-TIP RF ABLATION SINGLE ELECTRODE KIT
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COVIDIEN LP COOL-TIP RF SINGLE ELECTRODE KIT 10CM X 3CM; COOL-TIP RF ABLATION SINGLE ELECTRODE KIT Back to Search Results
Model Number ACT1030
Medical Device Problem Code Temperature Problem (3022)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).This complaint is part of a retrospective review as part of a remediation related to (b)(4).Although the device tested to specification in this case, in other similar incidents, medtronic¿s investigation identified the root cause to be inadequate solder joint between the device¿s thermocouple and inner tube.All identified corrective actions have been implemented including retraining of the operators on the soldering process, revalidation of the soldering process, the addition of a new electrical resistance tester, and revalidation of the thermocouple test process.
 
Event or Problem Description
The customer reported that the temperature was unstable.
 
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Brand Name
COOL-TIP RF SINGLE ELECTRODE KIT 10CM X 3CM
Common Device Name
COOL-TIP RF ABLATION SINGLE ELECTRODE KIT
Manufacturer (Section D)
COVIDIEN LP
5920 longbow drive
boulder CO 80301
MDR Report Key6370254
Report Number3006451981-2017-00194
Device Sequence Number13705035
Product Code NEY
UDI-Device Identifier10884524001159
UDI-Public0110884524001159171806011051460048X
Combination Product (Y/N)N
PMA/510(K) Number
K053290
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/28/2017
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 Health Professional
Device Model NumberACT1030
Device Catalogue NumberACT1030
Device Lot Number51460048X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/28/2017
Initial Report FDA Received Date03/01/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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