MAUDE Adverse Event Report: ATRICURE, INC. SYNERGY¿ ABLATION SYSTEM; SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number OLL2

Device Problem Defective Device (2588)

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

Event Date 08/19/2019

Event Type  malfunction  

Event Description

Oll2 atricure clamp.Was using for during procedure, fired couple times and then quit functioning.

• Brand Name: SYNERGY¿ ABLATION SYSTEM
• Type of Device: SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 9081483
• MDR Text Key: 159009394
• Report Number: 9081483
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 93418
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1