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

Model Number DU-BER-1808

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

It was reported by the healthcare facility that, during placement of a bonastent esophageal stent, the olive tip at the end of the delivery device fell off and was stuck inside the pt, below the site of the stent placement.The physician did not retrieve the part, which was allowed to pass naturally.There were no adverse effects on the pt.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 ESOPHAGEAL STENT
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): SEWOON MEDICAL CO., LTD.; seoul ; KS
• Manufacturer (Section G): ENDOCHOICE INC.; 11810 wills rd; alpharetta GA 30009 000
• Manufacturer Contact: 11810 wills rd; alpharetta, GA 30009-0000
• MDR Report Key: 4692073
• MDR Text Key: 5646120
• Report Number: 3007591333-2015-00009
• Device Sequence Number: 1
• Product Code: ESW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/13/2015

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: Health Professional
• Device Expiration Date: 09/26/2017
• Device Model Number: DU-BER-1808
• Device Catalogue Number: DU-BER-1808
• Device Lot Number: 140926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/19/2015
• Device Age: 5 MO
• Date Report to Manufacturer: 03/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1