MAUDE Adverse Event Report: TACT SURGICAL LLC/ ATRICURE INC. NCONTACT SURGICAL LLC; COAGULATION CABLE

Model Number CSK-2000

Device Problems Device Inoperable (1663); Device Operational Issue (2914)

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

Event Date 03/17/2017

Event Type  malfunction  

Event Description

Failure of coagulation rf cable.

• Brand Name: NCONTACT SURGICAL LLC
• Type of Device: COAGULATION CABLE
• Manufacturer (Section D): TACT SURGICAL LLC/ ATRICURE INC. ; raleigh NC 27601
• MDR Report Key: 6435750
• MDR Text Key: 70999951
• Report Number: MW5068656
• Device Sequence Number: 1
• Product Code: NCO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2017
• Device Model Number: CSK-2000
• Device Lot Number: 69631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 109