MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR SYNERGY ENCOMPASS CLAMP; ELECTROSURGICAL DEVICE

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	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event described is a known defect that has been observed previously and documented.This defect was investigated, and a deviation was implemented for immediate mitigation of the defect.Lot 129744 was manufactured prior to the implementation of the deviation.
Event or Problem Description
A patient had aortic valve repair/replacement and aortic root procedure, with concomitant ablation and left atrial appendage exclusion.After completing ablation with olh device, when physician released the device's closure lever, the blue plunger insert on the lever detached and landed within the sterile field.The procedure was successfully completed with the device, and no patient harm was reported.

• Brand Name: ISOLATOR SYNERGY ENCOMPASS CLAMP
• Common Device Name: ELECTROSURGICAL DEVICE
• 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: 19906939
• Report Number: 3011706110-2024-00048
• Device Sequence Number: 7037353
• Product Code: OCL
• UDI-Device Identifier: 10840143905834
• UDI-Public: (01)10840143905834(17)260501(10)129744
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K221358
• 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): 08/05/2024

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: 05/01/2026
• Device Model Number: OLH
• Device Catalogue Number: A001143
• Device Lot Number: 129744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• 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