MAUDE Adverse Event Report: ATRICURE, INC. SURGICAL ABLATION SYSTEM; SURGICAL DEVICE FOR CUTTING COAGULATION, AND/OR ABLATION OF TISSUE

Model Number	OLL2
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On the first attempt/location the instrument worked properly.The second attempt/location the instrument would not complete nor would it beep.The physician attempted more times and could not get the desired effect.Instrument was removed from the field and replaced with a new one.(b)(4).

• Brand Name: SURGICAL ABLATION SYSTEM
• Common Device Name: SURGICAL DEVICE FOR CUTTING COAGULATION, AND/OR ABLATION OF TISSUE
• Manufacturer (Section D): ATRICURE, INC.
• MDR Report Key: 8306050
• Report Number: MW5083690
• Device Sequence Number: 2253791
• Product Code: OCL
• UDI-Device Identifier: 00818354010503
• UDI-Public: (01)00818354010503(17)211001(10)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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: 10/01/2021
• Device Model Number: OLL2
• Device Catalogue Number: OLL2
• Device Lot Number: 88487
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 46