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

Model Number	ACT2020
Medical Device Problem Codes	Aborted Charge (2288); No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the device failed to circulate.The procedure was interrupted.There was no injury caused to the patient.
Additional Manufacturer Narrative
Evaluation summary: one device and one inflow tubing set 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 the luer broke at the orange/blue tubing junction.The reported condition was confirmed.The investigation found the luer broke at the orange/blue tubing junction.The investigation identified the root cause of the reported event to be a component.A scar has been issued to the supplier.The investigation found the device did not allow water to circulate through.The tubing was not blocked.The needle was removed and fiber was found at the tip of the hypotube/ thermocouple assembly.Engineering and the supplier have examined all the manufacturing processes for the needles.Nothing in the supplier or manufacturing process would contribute to the fibers found.The investigation identified the root cause of the reported event to be user error.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: 7363329
• Report Number: 1717344-2018-00381
• Device Sequence Number: 13495937
• Product Code: GEI
• UDI-Device Identifier: 10884524001210
• UDI-Public: 10884524001210
• 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: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: ACT2020
• Device Catalogue Number: ACT2020
• Device Lot Number: 61760146X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR