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

Model Number	OLH
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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)
• Common Device Name: 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
• Report Number: 3011706110-2023-00035
• Device Sequence Number: 15227627
• Product Code: OCL
• UDI-Device Identifier: 10840143905834
• UDI-Public: (01)10840143905834(17)260601(10)131278
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K210477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown