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

Model Number BERR

Device Problem Misfire (2532)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2015

Event Type  malfunction  

Event Description

It was reported that the stent was "misfired/unable to recapture".It was not reported if this malfunction caused injury or other negative health consequence to any patient.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 0000
• Manufacturer Contact: 11810 wills rd; alpharetta, GA 30009-0000
• MDR Report Key: 5091466
• MDR Text Key: 26483845
• Report Number: 3007591333-2015-00046
• 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: Not Applicable
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• Device Model Number: BERR
• Device Catalogue Number: DU-BER-1808
• Device Lot Number: 140915
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/20/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2015
• 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