MAUDE Adverse Event Report: COVIDIEN LP COOL-TIP SINGLE ELEC 15CM X 3CM KIT; COOL-TIP RF ABLATION SINGLE ELECTRODE KIT

Model Number	ACT1530
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
Covidien reference #:(b)(4).Date of initial report: 09 mar 2017.This complaint is part of a retrospective review as part of a remediation related to capa (b)(4).Medtronic¿s investigation found that the device did not read the temperature properly.The investigation identified the root cause to be inadequate solder joint between the device¿s thermocouple and inner tube.Corrective action has been issued for this failure.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 electrode did not work, there was no show measurement of temperature.A new device was used to complete the procedure.No patient harm.

• Brand Name: COOL-TIP SINGLE ELEC 15CM X 3CM KIT
• Common Device Name: COOL-TIP RF ABLATION SINGLE ELECTRODE KIT
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 6391025
• Report Number: 1717344-2017-00264
• Device Sequence Number: 500969
• Product Code: NEY
• UDI-Device Identifier: 10884524001203
• UDI-Public: 0110884524001203171804011051040035X
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K053290
• Number of Events Summarized: 1
• 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 Number: ACT1530
• Device Catalogue Number: ACT1530
• Device Lot Number: 51040035X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1