MAUDE Adverse Event Report: TAEWOONG MEDICAL CO., LTD NITI-S ESOPHAGEAL COVERED STENT; ESOPHAGEAL STENT

Model Number EST1810F

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2015

Event Type  malfunction  

Manufacturer Narrative

Since the suspected (or event) device was not returned, we inspected the device history records.It was confirmed by reviewing the device history records of the device that there was nothing significant, that it was manufactured normally, and that if passed all the inspections/tests.There is no pt info, and since it is difficult to reconstruct at that time in the lab and limited info, it is hard to find out exact root cause for this complaint.And the complaint will continue to be monitored for same case.

Event Description

Est1810f stent failed to deploy and the handle broke.It was confirmed that there was no pt injury and the facility destroyed the stent due to concerns of cross contamination.

• Brand Name: NITI-S ESOPHAGEAL COVERED STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; goyang-si, kyunggi-do ; KS
• Manufacturer Contact: 14, gojeong-ro, wolgot-myeon; goyang-si, kyunggi-do ; 19960641
• MDR Report Key: 4729699
• MDR Text Key: 120706511
• Report Number: 3003902943-2015-00019
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2017
• Device Model Number: EST1810F
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1