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

Model Number	ACTC2025
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date 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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during the radiofrequency ablation procedure the temperature displayed on the screen remained at around 95 degrees centigrade.The physician shut down the device, checked the water circulation, return electrode and connecting cable.Nothing wrong was found.Then the physician replaced the electrode and finished the procedure without incident.There was no injury to the patient.
Additional Manufacturer Narrative
One actc2025 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 the device was received with the cable cut off.The cable was not returned.Not enough cable remained to splice a new one on, preventing functional testing.The handle was removed and no anomalies were noted inside the device which would have contributed to the reported event.The investigation could not determine the root cause of the customer's report.The customer is advised to return the device intact so a complete analysis can be performed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during the procedure of radiofrequency ablation the temperature displayed on the screen remained at around 95 degree centigrade.The physician shut down the device and checked the water circulation, negative plate and connecting cable.Nothing wrong was found.Then the physician replaced the needle electrode and finished the procedure.There was no injury to the patient.

• 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: 6555005
• Report Number: 1717344-2017-05310
• Device Sequence Number: 18966104
• Product Code: GEI
• UDI-Device Identifier: 10884524001197
• UDI-Public: 10884524001197
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: ACTC2025
• Device Catalogue Number: ACTC2025
• Device Lot Number: 62710156X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1