MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER COOL-TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ACTC1525
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit had an alarm problem also, before the start of the operation for a liver tumor, the radio frequency machine passed the self-test and the rf needle was inserted.When the ablation was ready, the temperature window showed a rapid increase in temperature.Being that high, the device automatically shuts down after hh, the operation was successful after replacing the rf needle.There was no patient involvement.
Additional Manufacturer Narrative
One device was received for evaluation.The returned product did not meet specification as received.Visual inspection found no defects.The reported condition was confirmed.The water circulated normally through the sample.The device did not read the temperature properly.The needle was removed.The solder joint at the tip of the thermocouple was found to be broken.The investigation identified the root cause of the reported event to be a poor solder joint.Corrective actions have been implemented to mitigate this issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COOL-TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7882772
• Report Number: 1717344-2018-01235
• Device Sequence Number: 19287469
• Product Code: GEI
• UDI-Device Identifier: 10884524001203
• UDI-Public: 10884524001203
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 10/25/2020
• Device Model Number: ACTC1525
• Device Catalogue Number: ACTC1525
• Device Lot Number: 73140158X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1