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

Model Number	ACT1520
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The customer reported the temperature was not displayed after puncturing.There was no patient harm.Another device was used to complete the procedure.
Additional Manufacturer Narrative
One act1520 was received for evaluation.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.Visual inspection found no defects.The customer reported that the temperature was not stable.The reported condition was confirmed.The water circulated normally through the sample but the sample did not read the temperature properly.Evaluation found the thermocouple solder joint was broken.This is a manufacturing related failure.Corrective action was implemented subsequent to the manufacture of the incident device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported the temperature was not displayed after starting the ablation.There was no patient harm.Another device was used to complete the procedure.

• 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: 6457050
• Report Number: 1717344-2017-05184
• Device Sequence Number: 621985
• Product Code: GEI
• UDI-Device Identifier: 10884524001180
• UDI-Public: 10884524001180
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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: 09/01/2019
• Device Model Number: ACT1520
• Device Catalogue Number: ACT1520
• Device Lot Number: 62560335X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1