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

Model Number 401-152

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2018

Event Type  malfunction  

Event Description

The estech retractor was faulty and became disassembled during use.All pieces were collected by the surgeon and handed off.Manager of spd called and given broken equipment.Record reviewed, no evidence of patient harm noted.Surgery concluded without complication.

• Brand Name: HERCULES UNIVERSAL STABILIZER ARM
• Type of Device: RETRACTOR
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 7424873
• MDR Text Key: 105274715
• Report Number: 7424873
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 401-152
• Other Device ID Number: CONTROL # 6.860.668
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR