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	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no reported injury to the patient.Device evaluation concluded there was indication of a material or manufacturing process issue.This failure mode is being reported as the presumption that the malfunction is likely to cause or contribute to a serious injury has been previously established.
Event or Problem Description
The surgeon reported the endoscope retainer band broke during insertion of the device.No additional details were provided by the customer.The device was successfully and uneventfully removed and the case was aborted.There were no adverse patient effects.

• 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: 6487100
• Report Number: 3005473391-2017-00100
• Device Sequence Number: 624563
• Product Code: ODE
• UDI-Device Identifier: 00810275011065
• UDI-Public: (01)00810275011065(17)181111(10)402371
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

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: 11/11/2018
• Device Model Number: C02042-01
• Device Catalogue Number: R2005
• Device Lot Number: 402371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR