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)
Date of Event	02/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien reference #: (b)(4).Date of initial report: 03/03/2017.This complaint is part of a retrospective review as part of a remediation related to capa(b)(4).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 device could not sense the correct temperature and the temperature was fluctuating on the monitor.The issue was found prior to use and there was no patient injury.

• 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
• MDR Report Key: 6378662
• Report Number: 1717344-2017-00230
• Device Sequence Number: 551982
• Product Code: NEY
• UDI-Device Identifier: 10884524000947
• UDI-Public: 0110884524000947171804011050920105X
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• 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 Expiration Date: 04/30/2018
• Device Model Number: ACT1530
• Device Catalogue Number: ACT1530
• Device Lot Number: 50920105X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1