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

Model Number	C02042-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although there was no indication of an injury to the patient or a manufacturing process issue, this failure mode is now being reported due to previously establishing that if this malfunction were to reoccur, a serious injury may occur.
Event or Problem Description
Surgeon was in the initial process of inserting device down the patient's esophagus.The device was in the proximal esophagus when the surgeon experienced some resistance in progressing down the esophagus.The physician extracted the device.Following removal it was noticed the elastic band which holds the distal tip of the endoscope in place against the distal tip of the device during insertion was broken.There were no adverse patient effects and a second device was opened and used to successfully complete the procedure.

• Brand Name: ESOPHYX2 HD
• Common Device Name: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th street; suite 100; redmond WA 98052 5022
• MDR Report Key: 5368436
• Report Number: 3005473391-2015-00094
• Device Sequence Number: 16329549
• Product Code: ODE
• UDI-Device Identifier: 00810275011065
• UDI-Public: (01)00810275011065(17)170831(10)402053
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/11/2016

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
• Operator of Device: Physician
• Device Expiration Date: 08/31/2017
• Device Model Number: C02042-01
• Device Catalogue Number: R2005
• Device Lot Number: 402053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2015
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 68