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.

Manufacturer Narrative

Exact cause cannot be analyzed because we did not collect the stent olive tip fell off and we do not know why olive tip fell off during any surgery.We confirm that there is no problem for adhesive process after we reviewed device history record according to lot number.We have not received any complaint from the goods of the same lot number.We tested tensile force, it was measured to 23.8n.Olive tip could fall off when a force is applied beyond the standard (15n).Therefore we assume that olive tip cannot fall off during a proper operation.The physician can remove olive tip by biopsy forceps or let olive tip pass naturally because there is no adverse effects on the pt.

• Brand Name: BONASTENT ESOPHAGEAL STENT
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): SEWOON MEDICAL CO., LTD; seoul ; KS
• Manufacturer Contact: tae cho ; 46 wangsan-ro; dongdaemum-gu; seoul ; KS ; 9226555
• MDR Report Key: 4730587
• MDR Text Key: 5705242
• Report Number: 3000247987-2015-00001
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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-BER1808
• 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
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2015
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 04/21/2015
• 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