MAUDE Adverse Event Report: NCONTACT SURGICAL, INC./ ATRICURE, INC NCONTACT EPI-SENSE 3CM; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Catalog Number CDK-1413

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2020

Event Type  Injury  

Event Description

Epi-sense 3cm guided coagulation system malfunctioned.Fda safety report id# (b)(4).

• Brand Name: NCONTACT EPI-SENSE 3CM
• Type of Device: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• Manufacturer (Section D): NCONTACT SURGICAL, INC./ ATRICURE, INC
• MDR Report Key: 10836873
• MDR Text Key: 216395762
• Report Number: MW5097848
• Device Sequence Number: 1
• Product Code: OCL
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: CDK-1413
• Device Lot Number: 86381
• 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: 76 YR