MAUDE Adverse Event Report: COVIDIEN LP COOL-TIP SINGLE ELECTRODE 15CM X 2CM KIT; ACT ONES - COOL-TIP RF ABLATION SINGLE ELECTRODE KIT

Model Number	ACT1520
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of initial report: (b)(6) 2017.This complaint is part of a retrospective review as part of a remediation related to capa (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 prior to use on a patient, temperature was not shown on the display upon connecting subject needle to the generator.Another needle was used to complete the case.No patient involvement.

• Brand Name: COOL-TIP SINGLE ELECTRODE 15CM X 2CM KIT
• Common Device Name: ACT ONES - COOL-TIP RF ABLATION SINGLE ELECTRODE KIT
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 6368415
• Report Number: 1717344-2017-00193
• Device Sequence Number: 768444
• Product Code: NEY
• UDI-Device Identifier: 10884524001180
• UDI-Public: 0110884524001180171706011041490048X
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: ACT1520
• Device Catalogue Number: ACT1520
• Device Lot Number: 41490048X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1