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

Model Number	ACT1530
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2018
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, intra-operatively, the electrode was connected to the generator and the pump was started and ablation was performed.The temperature was unstable and an error occurred after few seconds.The electrode was replaced with new one and the new one worked fine.There was no patient harm.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: evaluation summary: one device was received for evaluation.Visual inspection found no defects.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.The water circulated normally through the sample.The sample read the temperature properly.This unit does not meet the requirements for a manufacturing failure.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: 7710764
• Report Number: 1717344-2018-00954
• Device Sequence Number: 1107799
• Product Code: GEI
• UDI-Device Identifier: 10884524000947
• UDI-Public: 10884524000947
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K973297
• 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,Followup
• Report Date (Section B): 10/23/2018

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 Model Number: ACT1530
• Device Catalogue Number: ACT1530
• Device Lot Number: 73450195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/28/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1