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	09/21/2017
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 that during the procedure, the temperature increased until the unit shut down.Another device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.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 device.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: 6963898
• Report Number: 1717344-2017-06086
• Device Sequence Number: 1549854
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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: 04/07/2020
• Device Model Number: ACTC2025
• Device Catalogue Number: ACTC2025
• Device Lot Number: 70580188X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 09/23/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR