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

Model Number	ACT2020
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
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, during a procedure for a liver tumor, the device had a loop and leak problem on its water pipe.The doctor had to use more needle sets.There was no patient injury.
Additional Manufacturer Narrative
One set of inflow tubing was received for evaluation.The device was not received for evaluation.The returned product did not meet specification as received.Visual inspection found the luer broke at the orange/blue tubing junction.The customer reported that the device was broken.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.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: 7873259
• Report Number: 1717344-2018-01219
• Device Sequence Number: 1909420
• Product Code: GEI
• UDI-Device Identifier: 10884524001210
• UDI-Public: 10884524001210
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

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: 05/11/2020
• Device Model Number: ACT2020
• Device Catalogue Number: ACT2020
• Device Lot Number: 71510227X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR