MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR SYNERGY; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Catalog Number P000319C

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

An atricure device was opened for the surgeon to perform a "maze" procedure.The device was opened and plugged into the appropriate machine.When activated by the surgeon, it did not work and an error message appeared.It was removed and plugged into another machine.The device then showed another error code, indicating an error at the hand piece.Staff opened a new hand piece and the device then functioned properly on both machines.

• Brand Name: ISOLATOR SYNERGY
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): ATRICURE, INC.; 6217 centre park drive; west chester OH 45069
• MDR Report Key: 4029739
• MDR Text Key: 18575018
• Report Number: 4029739
• Device Sequence Number: 1
• Product Code: OCL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: P000319C
• Device Lot Number: 500079F
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 90