MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION 150 ABLATION SYSTEM

Model Number 001-700-001S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon inspection and unrelated to the initial complaint reported the magnet cap had failed allowing the magnet to be pulled from the distal end of the fusion end effector.The magnet was returned stuck to the long tape introducer.Upon inspection the complaint was confirmed with this device; the root cause of this is unknown and appears to be unrelated to the device, as the device was plugged into a known good esu without the issues seen on the esu returned with the complaint.

Event Description

On (b)(6) 2016, during the a concomitant procedure, it was difficult to deselect the ''3'' segment when pressing the button, they called for assistance and after several attempts succeeded to deselect.They were able to finish the ablation and complete the case.On (b)(6) 2016, when performing a concomitant case, it was difficult to deselect the ''3'' segment when pressing button.It was not possible to fix the issue, so they were not able to finish the ablation.As the surgeon didn't want to ablate again on the segment number '3'', he had to stop the procedure before ablation of segments '4'', '5'', "6''.The procedure was prolonged.The patient was on pump and heparinized.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555320
• MDR Report Key: 5938206
• MDR Text Key: 54281777
• Report Number: 3003502395-2016-00104
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001-700-001S
• Device Catalogue Number: 001-700-001S
• Device Lot Number: 14055-032615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COBRA ELECTROSURGICAL UNIT