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

Model Number OLL2

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  Injury  

Event Description

Disposable atricure handpiece malfunctioned during the procedure.The energy on the machine display did not show the appropriate scale.After the handpiece was changed, the procedure went as planned without any further disruptions.No harm to the patient.Fda safety report id # (b)(4).

• Brand Name: SURGICAL ABLATION SYSTEM
• Type of Device: SURGICAL CARDIAC ABLATION DEVICE FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ATRICURE, INC.
• MDR Report Key: 9458861
• MDR Text Key: 170729304
• Report Number: MW5091615
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 71444
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 90