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

Model Number C02042-01

Device Problem Device Issue (2379)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/29/2018

Event Type  Injury  

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 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
• Type of Device: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th st.; suite 100; redmond WA 98052
• Manufacturer (Section G): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th st; suite 100; redmond WA 98052
• Manufacturer Contact: james brooks ; 18109 ne 76th st; suite 100; redmond, WA 98052 ; 4253079233
• MDR Report Key: 7452100
• MDR Text Key: 106213110
• Report Number: 3005473391-2018-00110
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011065
• UDI-Public: (01)00810275011065(17)190228(10)402429
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 84