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

Model Number 001-401-152

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number was not reported.Hercules is a reusable device, there was no reported patient harm.

Event Description

On 4/16/2018, information received through facility filed medwatch.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, no evidence of patient harm noted.Surgery concluded without complication.

• 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: anupam bedi ; 7555 innovations way; mason, OH 45040
• MDR Report Key: 7502771
• MDR Text Key: 108291817
• Report Number: 3011706110-2018-00160
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D233474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 001-401-152
• Device Catalogue Number: 001-401-152
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2018
• 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
• Patient Age: 69 YR