MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC. ESOPHYX2 HD; ODE

Model Number	C02042-01
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was available for evaluation.After conducting an engineering evaluation, the following items were noted: the endoscope retainer band failed due to a tensile fracture, no sharps were found on the device tissue mold/chassis.A review of the product dhr indicates all components used in this product lot are within specification and the device passed normal manufacturing final acceptance testing.No definitive root cause has been identified for the perforation.
Event or Problem Description
The physician noted the silicone endoscope retainer band was broken immediately after device insertion and a portion of the retainer band had separated from the device and was laying in the patient's stomach.The physician decided not to retrieve the separated portion of the retainer band and successfully completed the tif procedure.During the post-procedure egd, an esophageal perforation (the size was not reported) was noted just proximal to the most proximal deployed fastener in the gej.The physician successfully treated the perforation using a stent and sutures.The patient was admitted to the hospital (b)(6) 2018 and was discharged (b)(6) 2018.

• Brand Name: ESOPHYX2 HD
• Common Device Name: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th st.; suite 100; redmond WA 98052
• MDR Report Key: 7452100
• Report Number: 3005473391-2018-00110
• Device Sequence Number: 1642702
• Product Code: ODE
• UDI-Device Identifier: 00810275011065
• UDI-Public: (01)00810275011065(17)190228(10)402429
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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
• Operator of Device: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: C02042-01
• Device Catalogue Number: R2005
• Device Lot Number: 402429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 84