MAUDE Adverse Event Report: ATRICURE, INC. UNIVERSAL STABILIZER ARM, HERCULES 3

Model Number 001-401-161

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was evaluated on 10/26/2017.Upon evaluation, the complaint was confirmed.It was identified that the two lock plates were missing, making the device locking mechanism inoperable.This deficiency was found post-sterilization.Further investigation is required for this device malfunction.There was no reported patient involvement.

Event Description

On (b)(4) 2017, it was reported that the hercules 3 universal stabilizer arm was broken.Per the customer, the device was received broken upon return from sterile processing.Due to the nature of the device malfunction, it could not be used for any procedures.The device is under warranty.There was no reported patient involvement.

• Brand Name: UNIVERSAL STABILIZER ARM, HERCULES 3
• Type of Device: UNIVERSAL STABILIZER ARM, HERCULES 3
• 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
• MDR Report Key: 7054307
• MDR Text Key: 93233681
• Report Number: 3011706110-2017-00100
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2017

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: Other Health Care Professional
• Device Expiration Date: 07/27/2018
• Device Model Number: 001-401-161
• Device Catalogue Number: 001-401-161
• Device Lot Number: 71084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2016
• 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