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 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4)- the device was returned for investigation and the complaint was confirmed as the plunger insert is missing and not returned.No further analysis could be conducted.

Event Description

A male patient underwent an on-pump coronary artery bypass graft (cabg) with aortic valve replacement (avr).When the doctor pushed the release button for the closure lever of the olh clamp, the plunger insert detached, exited and reentered sterile field.The clamp still functioned, and case was completed without delay.There was no patient harm reported and detached piece did not enter patient's chest cavity.

• 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: 16694293
• MDR Text Key: 312865896
• Report Number: 3011706110-2023-00015
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 00818354017496
• UDI-Public: (01)00818354017496(17)260101(10)126657
• 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: 04/06/2023

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
• Device Operator: Health Professional
• Device Model Number: OLH
• Device Catalogue Number: A001143
• Device Lot Number: 126657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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
• Patient Sex: Male