MAUDE Adverse Event Report: ATRICURE, INC. SI RETRACTOR BLADE; SI RETRACTOR BLADE, 40W X 50L, STANDARD

Model Number 001-400-172

Device Problems Fracture (1260); Material Separation (1562)

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

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4): device was not returned for evaluation.A supplement will be submitted if the device is returned.There was no reported patient impact.

Event Description

On (b)(6) 2018, a patient received a mini avr procedure using an atricure si retractor blade.During the procedure, the blade broke but no parts fell into the patient¿s body cavity.There was no reported patient impact.

Manufacturer Narrative

(b)(4).The device evaluation was completed on 4/30/2018, the complaint was confirmed.The device was received in two pieces.The nipple had been broken from the blade at the welded joint.

• Brand Name: SI RETRACTOR BLADE
• Type of Device: SI RETRACTOR BLADE, 40W X 50L, STANDARD
• 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: 7343527
• MDR Text Key: 103149127
• Report Number: 3011706110-2018-00141
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 001-400-172
• Device Catalogue Number: 001-400-172
• Device Lot Number: 2016/07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2018
• 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: Initial
• Patient Sequence Number: 1