MAUDE Adverse Event Report: SEWOON MEDICAL CO., LTD. BONASTENT; PROSTHESIS, ESOPHAGEAL

Model Number NOT REPORTED

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/25/2015

Event Type  Injury  

Event Description

It was reported that in a case involving two esophageal cancers, in which the lower third was stented and the upper third had rt.The stent had fractured into two pieces, in which one part was mid-third in the esophagus and the other half had moved into the stomach.The product model and catalog number were not reported with this incident, which occurred outside of the u.S.Therefore, this report is submitted under the assumption that the model involved is marketed in the u.S.This report is being generated out of an abundance of caution.Submission of this report does not, in itself, represent a conclusion that the medical device caused or contributed to an adverse event.

• Brand Name: BONASTENT
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): SEWOON MEDICAL CO., LTD.; seoul ; KN
• Manufacturer (Section G): ENDOCHOICE INC.; 11810 wills rd; alpharetta GA 30009 0000
• Manufacturer Contact: 11810 wills rd; alpharetta, GA 30009-0000
• MDR Report Key: 5197092
• MDR Text Key: 30323951
• Report Number: 3007591333-2015-00061
• Device Sequence Number: 1
• Product Code: ESW
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT REPORTED
• Device Catalogue Number: NOT REPORTED
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2015
• Distributor Facility Aware Date: 09/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1