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

Model Number OLL2

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/28/2019

Event Type  malfunction  

Event 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
• Type of Device: SURGICAL DEVICE FOR CUTTING COAGULATION, AND/OR ABLATION OF TISSUE
• Manufacturer (Section D): ATRICURE, INC.
• MDR Report Key: 8306050
• MDR Text Key: 135734450
• Report Number: MW5083690
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 00818354010503
• UDI-Public: (01)00818354010503(17)211001(10)
• Combination Product (y/n): N
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• 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: 51 YR
• Patient Weight: 46