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

Model Number 001-401-161

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

Case-(b)(4) the device was returned and an evaluation for the hercules 3 ¿ lot number 72808 was performed.The complaint was confirmed upon receipt of the device and with photographic evidence by the distributor.One of the two lock plates was missing and was not returned with the product.As a result, the retractor mount locking mechanism was not functioning as intended.There was no patient involvement for this complaint.

Event Description

It was reported that on (b)(6) 2018 while the facility was doing a maintenance inspection, the locking plate of the hercules 3 arm was found cracked.The hospital states device was used for only 10 months.There was no patient involvement associated with this malfunction.

• 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: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5137554563
• MDR Report Key: 8267414
• MDR Text Key: 135371504
• Report Number: 3011706110-2019-00006
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: D233474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/22/2019

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
• Device Model Number: 001-401-161
• Device Catalogue Number: 001-401-161
• Device Lot Number: 72808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/22/2019
• 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