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

Model Number 001-401-161

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

Case: (b)(4); the device has not been returned but is anticipated; once additional information is received, a supplemental will be submitted.A device history review has been obtained for lot number 72418.There is nothing in the device history record that would indicate that the devices were released with any non-conformance's that would contribute to the complaint.

Event Description

On (b)(6) 2018, nurse manager opened a kit containing hercules 3 retractor in order to compare with a broken hercules retractor.At this time the newly opened hercules retractor was visually noted to have the top metal piece cracked in half.When spring was retracted half of the metal pieces fell out and the piece under spring was removed with the lower metal piece remaining in place.No patient involvement.

Manufacturer Narrative

Case-(b)(4).The device was returned for evaluation and visually and functionally tested.The complaint was confirmed, the back jaw becomes stuck in the open position, the locking plates were broken.There was no patient involvement with this complaint.

Manufacturer Narrative

Case-(b)(4).The device has not been returned to date but is anticipated.The facility confirmed through email release and shipment of the device to the company.When additional information/evaluation is available, the supplemental information will be submitted.

• 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 ; 7555 innovation way; mason, OH 45212
• MDR Report Key: 7656813
• MDR Text Key: 112999933
• Report Number: 3011706110-2018-00183
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 001-401-161
• Device Catalogue Number: 001-401-161
• Device Lot Number: 72418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1