MAUDE Adverse Event Report: ATRICURE, INC. ENCOMPASS SYNERGY CLAMP (LONG)

Model Number OLH

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, a patient underwent an aortic valve, myectomy, and concomitant maze procedure.During the maze portion of the procedure, the blue plunger insert of the closure lever detached when the clamp was released and fell into the sterile field.The procedure was completed with the device.There was no reported patient injury.

Manufacturer Narrative

(b)(4).The olh (lot# 131278) was returned for investigation.Upon visual inspection, the blue plunger insert was missing, and the complaint was confirmed.

• Brand Name: ENCOMPASS SYNERGY CLAMP (LONG)
• Type of Device: ENCOMPASS SYNERGY CLAMP (LONG)
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 17875912
• MDR Text Key: 324976871
• Report Number: 3011706110-2023-00035
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 10840143905834
• UDI-Public: (01)10840143905834(17)260601(10)131278
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OLH
• Device Catalogue Number: A001143
• Device Lot Number: 131278
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1