MAUDE Adverse Event Report: ATRICURE, INC. HERCULES UNIVERSAL STABILIZER ARM

Model Number 001-401-152

Device Problem Material Separation (1562)

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for investigation.However a device history record review was conducted, and there is nothing in the product history record that would indicate that the assembly was released with any non-conformances that would contribute to the subject complaint.

Event Description

Complaint information was sent by terumo.During a surgical valvular procedure, a hercules 3 universal stabilizer arm was employed.However, during the tightening of the device, the cable unexpectedly broke, resulting in pieces detaching from the stabilizer arm.The procedure was successfully completed.Subsequent x-ray imaging confirmed that no fragments had fallen into the patient.

• Brand Name: HERCULES UNIVERSAL STABILIZER ARM
• Type of Device: HERCULES UNIVERSAL STABILIZER ARM
• 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 45140 ; 5136448220
• MDR Report Key: 19149692
• MDR Text Key: 340679119
• Report Number: 3011706110-2024-00028
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2024

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
• Device Operator: Health Professional
• Device Model Number: 001-401-152
• Device Catalogue Number: 001-401-152
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1