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 12/28/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 a male patient underwent on on-pump, heparinized coronary artery bypass graft with concomitant maze procedure.When repositioning the olh clamp, the plunger insert of the closure lever detached and landed in the chest cavity.It was retrieved without patient harm.

Manufacturer Narrative

Case-(b)(4).Device failed visual inspection for the plunger insert missing from the device.Device passed functional check, electrical inspection, and performance evaluation.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: 16254135
• MDR Text Key: 308465196
• Report Number: 3011706110-2023-00003
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 00818354017496
• UDI-Public: (01)00818354017496(17)250901(10)123580
• 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: 01/27/2023

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: 123580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male