MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS ESOPHYX Z FASTENER DELIVERY DEVICE; GASTROSCOPE

Model Number R2006

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/04/2015

Event Type  Injury  

Event Description

During transoral incisionless fundoplication (tif) procedure on (b)(6) 2015, a small clear plastic piece at the end of the device broke off and remained in the patient's stomach requiring surgical removal with a balloon catheter.

• Brand Name: ESOPHYX Z FASTENER DELIVERY DEVICE
• Type of Device: GASTROSCOPE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS; 18109 ne 76th street; suite 100 ; redmond WA 98052
• MDR Report Key: 5430846
• MDR Text Key: 38081825
• Report Number: 5430846
• Device Sequence Number: 1
• Product Code: FDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: R2006
• Device Lot Number: 402015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/04/2015
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2015
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR