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

Model Number EST2006F

Device Problems Hole In Material (1293); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

No significant thing was found and it successfully passed criteria of manufacturing and inspection as a result of confirmation of device history record for this device.It is, however, impossible to identify the exact root cause since there is no information of patient and it is hard to recreate the situation at the time of procedure.We decided to report mdr since there is possibility to occur patient's injury in the future although no injury has been found so far from the patient.In addition, it will be monitored for the similar complaints reported.If there is any update, we will send follow-up report.For "a.Patient information", we, taewoong and our distributor could not get more detailed patient information because the hospital did not open the patient information such as "2.Age at time of event", "date of birth", "3.Sex", and "4.Weight".

Event Description

It was an esophagogastroduodenoscopy(egd).Upon deployment, multiple holes were noted in the stent cover.There was no harm to the patient.

Manufacturer Narrative

Holes were found on the silicone cover of both body and head parts of the stent on the investigation of returned device.Stent was completely expanded and no foreign body was found on it.It is confirmed from the device history record that the suspected device had been manufactured with no significant issue and passed all the inspections.Existence of hole on the stent is inspected by this firm two times during coating process and half-finished product inspection process.In addition, it is confirmed from the inspection result certificate that it passed successfully.It is considered that holes were made during deployment of the stent according to the complaint description in which holes were found during procedure.It is, however, impossible to identify the exact root cause since there is no patient's information provided and it is hard to recreate the situation at the time of procedure.We will continuously monitor whether similar or same complaint occurs.For "a.Patient information", we, taewoong and our distributor could not get more detailed patient information because the hospital did not open them such as "age at time of event", "date of birth", "sex" and " weight.".

Event Description

It was an esophagogastroduodenoscopy(egd).Upon deployment, multiple holes were noted in the stent cover.There was no harm to the patient.

• Brand Name: NITI-S ESOPHAGEAL COVERED STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO., LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer Contact: sanghyung park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022 ; 19960641
• MDR Report Key: 5442990
• MDR Text Key: 38414314
• Report Number: 3003902943-2016-00007
• 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,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: EST2006F
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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